No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00889024304536 | 20-8000-010-30 | 20-8000-010-30 | HAW | Neurological Stereotaxic Instrument | 2 | NA | |
2 | 00889024304529 | 20-8000-010-29 | 20-8000-010-29 | OLO,HAW | Orthopedic Stereotaxic Instrument,Neurological Stereotaxic Instrument | 2 | NA | |
3 | 00889024304512 | 20-8000-010-28 | 20-8000-010-28 | HAW,OLO | Neurological Stereotaxic Instrument,Orthopedic Stereotaxic Instrument | 2 | NA | |
4 | 00889024304505 | 20-8000-010-27 | 20-8000-010-27 | HAW,OLO | Neurological Stereotaxic Instrument,Orthopedic Stereotaxic Instrument | 2 | NA | |
5 | 00889024304499 | 20-8000-010-26 | 20-8000-010-26 | OLO,HAW | Orthopedic Stereotaxic Instrument,Neurological Stereotaxic Instrument | 2 | NA | |
6 | 00889024304482 | 20-8000-010-25 | 20-8000-010-25 | OLO,HAW | Orthopedic Stereotaxic Instrument,Neurological Stereotaxic Instrument | 2 | NA | |
7 | 00889024304475 | 20-8000-010-24 | 20-8000-010-24 | OLO,HAW | Orthopedic Stereotaxic Instrument,Neurological Stereotaxic Instrument | 2 | NA | |
8 | 00889024304468 | 20-8000-010-23 | 20-8000-010-23 | HAW,OLO | Neurological Stereotaxic Instrument,Orthopedic Stereotaxic Instrument | 2 | NA | |
9 | 00889024304451 | 20-8000-010-22 | 20-8000-010-22 | OLO,HAW | Orthopedic Stereotaxic Instrument,Neurological Stereotaxic Instrument | 2 | NA | |
10 | 00889024304437 | 20-8000-010-20 | 20-8000-010-20 | OLO,HAW | Orthopedic Stereotaxic Instrument,Neurological Stereotaxic Instrument | 2 | NA | |
11 | 00889024304420 | 20-8000-010-19 | 20-8000-010-19 | OLO,HAW | Orthopedic Stereotaxic Instrument,Neurological Stereotaxic Instrument | 2 | NA | |
12 | 00889024304413 | 20-8000-010-18 | 20-8000-010-18 | OLO,HAW | Orthopedic Stereotaxic Instrument,Neurological Stereotaxic Instrument | 2 | NA | |
13 | 00889024304406 | 20-8000-010-17 | 20-8000-010-17 | OLO,HAW | Orthopedic Stereotaxic Instrument,Neurological Stereotaxic Instrument | 2 | NA | |
14 | 00889024304376 | 20-8000-010-14 | 20-8000-010-14 | OLO,HAW | Orthopedic Stereotaxic Instrument,Neurological Stereotaxic Instrument | 2 | NA | |
15 | 00889024304369 | 20-8000-010-13 | 20-8000-010-13 | OLO,HAW | Orthopedic Stereotaxic Instrument,Neurological Stereotaxic Instrument | 2 | NA | |
16 | 00889024304352 | 20-8000-010-12 | 20-8000-010-12 | HAW,OLO | Neurological Stereotaxic Instrument,Orthopedic Stereotaxic Instrument | 2 | NA | |
17 | 00889024304345 | 20-8000-010-11 | 20-8000-010-11 | HAW,OLO | Neurological Stereotaxic Instrument,Orthopedic Stereotaxic Instrument | 2 | NA | |
18 | 00889024304321 | 20-8000-010-09 | 20-8000-010-09 | OLO,HAW | Orthopedic Stereotaxic Instrument,Neurological Stereotaxic Instrument | 2 | NA | |
19 | 00889024304314 | 20-8000-010-07 | 20-8000-010-07 | OLO,HAW | Orthopedic Stereotaxic Instrument,Neurological Stereotaxic Instrument | 2 | NA | |
20 | 00889024304291 | 20-8000-010-01 | 20-8000-010-01 | HAW,OLO | Neurological Stereotaxic Instrument,Orthopedic Stereotaxic Instrument | 2 | NA | |
21 | 00889024305304 | 20-8011-020-00 | 20-8011-020-00 | OLO | Orthopedic Stereotaxic Instrument | 2 | NA | |
22 | 00889024305298 | 20-8011-019-00 | 20-8011-019-00 | OLO | Orthopedic Stereotaxic Instrument | 2 | NA | |
23 | 00889024305281 | 20-8011-018-00 | 20-8011-018-00 | OLO | Orthopedic Stereotaxic Instrument | 2 | NA | |
24 | 00889024305380 | 20-8011-028-50 | 20-8011-028-50 | OLO | Orthopedic Stereotaxic Instrument | 2 | NA | |
25 | 00889024305373 | 20-8011-028-00 | 20-8011-028-00 | OLO | Orthopedic Stereotaxic Instrument | 2 | NA | |
26 | 00889024305366 | 20-8011-027-50 | 20-8011-027-50 | OLO | Orthopedic Stereotaxic Instrument | 2 | NA | |
27 | 00889024305359 | 20-8011-027-00 | 20-8011-027-00 | OLO | Orthopedic Stereotaxic Instrument | 2 | NA | |
28 | 00889024305342 | 20-8011-026-00 | 20-8011-026-00 | OLO | Orthopedic Stereotaxic Instrument | 2 | NA | |
29 | 00889024305335 | 20-8011-025-00 | 20-8011-025-00 | OLO | Orthopedic Stereotaxic Instrument | 2 | NA | |
30 | 00889024492714 | 20-8011-013-01 | OLO | Orthopedic Stereotaxic Instrument | 2 | NA | ||
31 | 00889024492707 | 20-8000-000-21 | OLO | Orthopedic Stereotaxic Instrument | 2 | NA | ||
32 | 00889024492691 | 20-8000-000-15 | OLO | Orthopedic Stereotaxic Instrument | 2 | NA | ||
33 | 00889024305311 | 20-8011-021-00 | 20-8011-021-00 | OLO | Orthopedic Stereotaxic Instrument | 2 | NA | |
34 | 00889024305274 | 20-8011-017-00 | 20-8011-017-00 | OLO | Orthopedic Stereotaxic Instrument | 2 | NA | |
35 | 00889024492660 | 20-8000-020-27 | HAW | Neurological Stereotaxic Instrument | 2 | NA | ||
36 | 00889024479012 | 20-8000-080-11 | OLO | Orthopedic Stereotaxic Instrument | 2 | NA | ||
37 | 00889024479005 | 20-8000-080-10 | OLO | Orthopedic Stereotaxic Instrument | 2 | NA | ||
38 | 00889024305267 | 20-8011-013-00 | 20-8011-013-00 | OLO | Orthopedic Stereotaxic Instrument | 2 | NA | |
39 | 00889024304840 | 20-8000-020-10 | 20-8000-020-10 | HAW | Neurological Stereotaxic Instrument | 2 | NA | |
40 | 00889024305410 | 20-8011-042-00 | 20-8011-042-00 | OLO | Orthopedic Stereotaxic Instrument | 2 | NA | |
41 | 00889024304888 | 20-8000-020-14 | 20-8000-020-14 | HAW | Neurological Stereotaxic Instrument | 2 | NA | |
42 | 00889024304871 | 20-8000-020-13 | 20-8000-020-13 | HAW | Neurological Stereotaxic Instrument | 2 | NA | |
43 | 00889024304598 | 20-8000-010-37 | 20-8000-010-37 | OLO,HAW | Orthopedic Stereotaxic Instrument,Neurological Stereotaxic Instrument | 2 | NA | |
44 | 00889024305564 | 20-8014-014-00 | 20-8014-014-00 | OOG,MBH,JWH | Knee Arthroplasty Implantation System,Prosthesis, Knee, Patello/Femorotibial, Se Knee Arthroplasty Implantation System,Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer,Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 2 | NA | |
45 | 00889024304574 | 20-8000-010-35 | 20-8000-010-35 | OLO,HAW | Orthopedic Stereotaxic Instrument,Neurological Stereotaxic Instrument | 2 | NA | |
46 | 00889024305526 | 20-8011-070-03 | 20-8011-070-03 | HAW | Neurological Stereotaxic Instrument | 2 | NA | |
47 | 00889024305519 | 20-8011-070-02 | 20-8011-070-02 | HAW | Neurological Stereotaxic Instrument | 2 | NA | |
48 | 00889024305465 | 20-8011-056-52 | 20-8011-056-52 | OLO | Orthopedic Stereotaxic Instrument | 2 | NA | |
49 | 00889024304857 | 20-8000-020-11 | 20-8000-020-11 | HAW | Neurological Stereotaxic Instrument | 2 | NA | |
50 | 00889024305458 | 20-8011-056-51 | 20-8011-056-51 | OLO | Orthopedic Stereotaxic Instrument | 2 | NA |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 09351327000084 | 1250-1100,1250-1200 | Patient Specific Femoral Guide+Trial Femoral Head | Optimized Positioning System (OPS) Femoral | OPTIMIZED ORTHO PTY LTD | |
2 | 09351327000060 | 1248-1500, 1248-1700, 1250-1100,1250-1200 | Patient Specific Acetabular Guide ,Trial Acetabulum,Patient Specific Femoral Gui Patient Specific Acetabular Guide ,Trial Acetabulum,Patient Specific Femoral Guide and Trial Femoral Head | Optimiized Positioning System(OPS) and Optimized Postioning System(OPS)Femoral | OPTIMIZED ORTHO PTY LTD | |
3 | 09351327000053 | 1248-1500, 1248-1700, 1250-1100 | Patient Specific Acetabular Guide, Trial Acetabulum and Patient Specific Femoral Guide | Optimized Positioning System (OPS) and Optimized Postioning System (OPS) Femoral | OPTIMIZED ORTHO PTY LTD | |
4 | 09351327000046 | 1250-1200 | Trial Femoral Head | Optimized Ortho Positioning (OPS) Femoral | OPTIMIZED ORTHO PTY LTD | |
5 | 09351327000039 | 1250-1100 | Patient Specific Femoral Guide | Optimized Ortho Positioning (OPS) Femoral | OPTIMIZED ORTHO PTY LTD | |
6 | 08809282819957 | 111-083-L | Surgical Instrument | JEIL MEDICAL CORPORATION | ||
7 | 08809282819940 | 111-083-R | Surgical Instrument | JEIL MEDICAL CORPORATION | ||
8 | 08809282819933 | 111-082-L | Surgical Instrument | JEIL MEDICAL CORPORATION | ||
9 | 08809282819926 | 111-082-R | Surgical Instrument | JEIL MEDICAL CORPORATION | ||
10 | 08806390885751 | SO-111-228-R | Summa Orthopaedics System Surgical Instrument | JEIL MEDICAL CORPORATION | ||
11 | 08806390885744 | SO-111-228-L | Summa Orthopaedics System Surgical Instrument | JEIL MEDICAL CORPORATION | ||
12 | 08806390885737 | SO-111-227-R | Summa Orthopaedics System Surgical Instrument | JEIL MEDICAL CORPORATION | ||
13 | 08806390885720 | SO-111-227-L | Summa Orthopaedics System Surgical Instrument | JEIL MEDICAL CORPORATION | ||
14 | 08806390876285 | 111-230-R | Surgical Instrument | JEIL MEDICAL CORPORATION | ||
15 | 08806390876278 | 111-230-L | Surgical Instrument | JEIL MEDICAL CORPORATION | ||
16 | 08806390876261 | 111-229-R | Surgical Instrument | JEIL MEDICAL CORPORATION | ||
17 | 08806390876254 | 111-229-L | Surgical Instrument | JEIL MEDICAL CORPORATION | ||
18 | 08806390876247 | 111-228-R | Surgical Instrument | JEIL MEDICAL CORPORATION | ||
19 | 08806390876230 | 111-228-L | Surgical Instrument | JEIL MEDICAL CORPORATION | ||
20 | 08806390876223 | 111-227-R | Surgical Instrument | JEIL MEDICAL CORPORATION | ||
21 | 08806390876216 | 111-227-L | Surgical Instrument | JEIL MEDICAL CORPORATION | ||
22 | 08806390869492 | SO-111-095-L | Summa Orthopaedics System Surgical Instrument | JEIL MEDICAL CORPORATION | ||
23 | 08806390869485 | SO-111-095-R | Summa Orthopaedics System Surgical Instrument | JEIL MEDICAL CORPORATION | ||
24 | 08806390869478 | SO-111-083-L | Summa Orthopaedics System Surgical Instrument | JEIL MEDICAL CORPORATION | ||
25 | 08806390869461 | SO-111-083-R | Summa Orthopaedics System Surgical Instrument | JEIL MEDICAL CORPORATION | ||
26 | 08806390869454 | SO-111-082-L | Summa Orthopaedics System Surgical Instrument | JEIL MEDICAL CORPORATION | ||
27 | 08806390869447 | SO-111-082-R | Summa Orthopaedics System Surgical Instrument | JEIL MEDICAL CORPORATION | ||
28 | 08806390801423 | 111-095-R | Surgical Instrument | JEIL MEDICAL CORPORATION | ||
29 | 08806390801416 | 111-095-L | Surgical Instrument | JEIL MEDICAL CORPORATION | ||
30 | 08058964726087 | 900001 144818 | "Disposable cement spacer molds with metal reinforcement stem are indicated for "Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold atemporary hemi- shoulder replacement for skeletally mature patients undergoing a two-stagerevision procedure due to a septic process.The temporary prosthesis is molded using low viscosity polymethylmethacrylate bonecement and inserted into the humeral medullary canal and glenoid cavity of the shoulderfollowing removal of the existing humeral and glenoideal cavity implants and debridement.SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement.The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy(standard treatment approach to an infection).The hemi-shoulder prosthesis made from the SpaceFlex Shoulder disposable cement molds isnot intended for use more than 180 days, at which time it must be explanted and permanentdevices implanted or another appropriate treatment performed (e.g. resection arthroplasty,fusion, etc.).Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (lowviscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicatedfor patients who will consistently follow activity limitation throughout the implant period.The device can exclusively be used by competent healthcare personnel who has completescientific and anatomical knowledge." | SpaceFlex Shoulder | G21 SRL | |
31 | 08058964726070 | 900001 124818 | Disposable cement spacer molds with metal reinforcement stem are indicated for u Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold atemporary hemi- shoulder replacement for skeletally mature patients undergoing a two-stagerevision procedure due to a septic process.The temporary prosthesis is molded using low viscosity polymethylmethacrylate bonecement and inserted into the humeral medullary canal and glenoid cavity of the shoulderfollowing removal of the existing humeral and glenoideal cavity implants and debridement.SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement.The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy(standard treatment approach to an infection).The hemi-shoulder prosthesis made from the SpaceFlex Shoulder disposable cement molds isnot intended for use more than 180 days, at which time it must be explanted and permanentdevices implanted or another appropriate treatment performed (e.g. resection arthroplasty,fusion, etc.).Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (lowviscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicatedfor patients who will consistently follow activity limitation throughout the implant period.The device can exclusively be used by competent healthcare personnel who has completescientific and anatomical knowledge. | SpaceFlex Shoulder | G21 SRL | |
32 | 08058964726063 | 900001 124215 | Disposable cement spacer molds with metal reinforcement stem are indicated for u Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold atemporary hemi- shoulder replacement for skeletally mature patients undergoing a two-stagerevision procedure due to a septic process.The temporary prosthesis is molded using low viscosity polymethylmethacrylate bonecement and inserted into the humeral medullary canal and glenoid cavity of the shoulderfollowing removal of the existing humeral and glenoideal cavity implants and debridement.SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement.The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy(standard treatment approach to an infection).The hemi-shoulder prosthesis made from the SpaceFlex Shoulder disposable cement molds isnot intended for use more than 180 days, at which time it must be explanted and permanentdevices implanted or another appropriate treatment performed (e.g. resection arthroplasty,fusion, etc.).Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (lowviscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicatedfor patients who will consistently follow activity limitation throughout the implant period.The device can exclusively be used by competent healthcare personnel who has completescientific and anatomical knowledge. | SpaceFlex Shoulder | G21 SRL | |
33 | 08058964726056 | 900001 104818 | Disposable cement spacer molds with metal reinforcement stem are indicated for u Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold atemporary hemi- shoulder replacement for skeletally mature patients undergoing a two-stagerevision procedure due to a septic process.The temporary prosthesis is molded using low viscosity polymethylmethacrylate bonecement and inserted into the humeral medullary canal and glenoid cavity of the shoulderfollowing removal of the existing humeral and glenoideal cavity implants and debridement.SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement.The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy(standard treatment approach to an infection).The hemi-shoulder prosthesis made from the SpaceFlex Shoulder disposable cement molds isnot intended for use more than 180 days, at which time it must be explanted and permanentdevices implanted or another appropriate treatment performed (e.g. resection arthroplasty,fusion, etc.).Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (lowviscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicatedfor patients who will consistently follow activity limitation throughout the implant period.The device can exclusively be used by competent healthcare personnel who has completescientific and anatomical knowledge. | SpaceFlex Shoulder | G21 SRL | |
34 | 08058964726049 | 900001 104215 | Disposable cement spacer molds with metal reinforcement stem are indicated for u Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold atemporary hemi- shoulder replacement for skeletally mature patients undergoing a two-stagerevision procedure due to a septic process.The temporary prosthesis is molded using low viscosity polymethylmethacrylate bonecement and inserted into the humeral medullary canal and glenoid cavity of the shoulderfollowing removal of the existing humeral and glenoideal cavity implants and debridement.SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement.The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy(standard treatment approach to an infection).The hemi-shoulder prosthesis made from the SpaceFlex Shoulder disposable cement molds isnot intended for use more than 180 days, at which time it must be explanted and permanentdevices implanted or another appropriate treatment performed (e.g. resection arthroplasty,fusion, etc.).Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (lowviscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicatedfor patients who will consistently follow activity limitation throughout the implant period.The device can exclusively be used by competent healthcare personnel who has completescientific and anatomical knowledge. | SpaceFlex Shoulder | G21 SRL | |
35 | 08058964724977 | 900001 084215 | Disposable cement spacer molds with metal reinforcement stem are indicated for u Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold atemporary hemi- shoulder replacement for skeletally mature patients undergoing a two-stagerevision procedure due to a septic process.The temporary prosthesis is molded using low viscosity polymethylmethacrylate bonecement and inserted into the humeral medullary canal and glenoid cavity of the shoulderfollowing removal of the existing humeral and glenoideal cavity implants and debridement.SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement.The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy(standard treatment approach to an infection).The hemi-shoulder prosthesis made from the SpaceFlex Shoulder disposable cement molds isnot intended for use more than 180 days, at which time it must be explanted and permanentdevices implanted or another appropriate treatment performed (e.g. resection arthroplasty,fusion, etc.).Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (lowviscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicatedfor patients who will consistently follow activity limitation throughout the implant period.The device can exclusively be used by competent healthcare personnel who has completescientific and anatomical knowledge. | SpaceFlex Shoulder | G21 SRL | |
36 | 08033390216418 | 9013.67.146 | 9013.67.146 | PRIMA - Impactor Adaptor #6 | PRIMA | LIMACORPORATE SPA |
37 | 08033390230599 | 9CCS.10.001 | 9CCS.10.001 | ProMade shoulder 140° Reverse Resection Jig | SMR Shoulder | LIMACORPORATE SPA |
38 | 08033390226172 | 9CCS.13.003 | 9CCS.13.003 | Compactor S | SMR Shoulder | LIMACORPORATE SPA |
39 | 08033390226165 | 9CCS.13.002 | 9CCS.13.002 | Glenoid Drill Peg S | SMR Shoulder | LIMACORPORATE SPA |
40 | 08033390216821 | 9013.67.067 | 9013.67.067 | PRIMA - Metaphyseal Size ring #7 | PRIMA | LIMACORPORATE SPA |
41 | 08033390216814 | 9013.67.066 | 9013.67.066 | PRIMA - Metaphyseal Size ring #6 | PRIMA | LIMACORPORATE SPA |
42 | 08033390216807 | 9013.67.064 | 9013.67.064 | PRIMA - Metaphyseal Size ring #4 | PRIMA | LIMACORPORATE SPA |
43 | 08033390216791 | 9013.67.065 | 9013.67.065 | PRIMA - Metaphyseal Size ring #5 | PRIMA | LIMACORPORATE SPA |
44 | 08033390216784 | 9013.67.063 | 9013.67.063 | PRIMA - Metaphyseal Size ring #3 | PRIMA | LIMACORPORATE SPA |
45 | 08033390216777 | 9013.67.062 | 9013.67.062 | PRIMA - Metaphyseal Size ring #2 | PRIMA | LIMACORPORATE SPA |
46 | 08033390216760 | 9013.67.061 | 9013.67.061 | PRIMA - Metaphyseal Size ring #1 | PRIMA | LIMACORPORATE SPA |
47 | 08033390216609 | 9013.67.140 | 9013.67.140 | PRIMA - Impactor | PRIMA | LIMACORPORATE SPA |
48 | 08033390216470 | 9013.67.141 | 9013.67.141 | PRIMA - Impactor Adaptor #1 | PRIMA | LIMACORPORATE SPA |
49 | 08033390216463 | 9013.67.055 | 9013.67.055 | PRIMA - Metaphyseal Centering Guide - LEFT | PRIMA | LIMACORPORATE SPA |
50 | 08033390216456 | 9013.67.050 | 9013.67.050 | PRIMA - Metaphyseal Centering Guide - RIGHT | PRIMA | LIMACORPORATE SPA |