No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00842048154174 | 97-04M | 97-04M | Retractor Clamp | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
2 | 00842048154709 | 97-65G | 97-65G | 6.5mm Solid tap | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
3 | 00842048154693 | 97-55G | 97-55G | 5.5mm Solid tap | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
4 | 00842048154686 | 97-45G | 97-45G | 4.5mm Solid tap | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
5 | 00842048153955 | 97-02R11 | 97-02R11 | Blade, Size 11 | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
6 | 00842048153948 | 97-02R10 | 97-02R10 | Blade, Size 10 | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
7 | 00842048153931 | 97-02R09 | 97-02R09 | Blade, Size 9 | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
8 | 00842048154730 | 99-39M | 99-39M | Adapter, Female Hex, A/O Drive | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
9 | 00842048154723 | 99-38M | 99-38M | Adapter, Male Hex, 1/4 Drive | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
10 | 00842048154716 | 97-75G | 97-75G | 7.5mm Solid tap | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
11 | 00842048154846 | 99-82M | 99-82M | Adapter W Spin Sleeve, 1/4 Square | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
12 | 00842048154839 | 99-56M | 99-56M | Wire Cutter, 6 Inch | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
13 | 00842048154822 | 99-42G08 | 99-42G08 | Guide Wire, Smooth, NiTi, 2.0mm, Long | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
14 | 00842048154815 | 99-42G07 | 99-42G07 | Guide Wire, Smooth, NiTi, 2.0mm, Short | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
15 | 00842048154808 | 99-42G06 | 99-42G06 | Guide Wire, Smooth, NiTi, 1.4mm, Long | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
16 | 00842048154792 | 99-42G05 | 99-42G05 | Guide Wire, Smooth, NiTi, 1.4mm, Short | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
17 | 00842048154785 | 99-42G04 | 99-42G04 | Guide Wire, Smooth, 316LVM, 2.0mm, Long | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
18 | 00842048154778 | 99-42G03 | 99-42G03 | Guide Wire, Smooth, 316LVM, 2.0mm, Short | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
19 | 00842048154761 | 99-42G02 | 99-42G02 | Guide Wire, Smooth, 316LVM, 1.4mm, Long | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
20 | 00842048154754 | 99-42G01 | 99-42G01 | Guide Wire, Smooth, 316LVM, 1.4mm, Short | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
21 | 00842048154747 | 99-40M | 99-40M | Adapter, Female Hex, 1/4 Drive | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
22 | 00842048154679 | 97-53P | 97-53P | 4mm Hex Socket Driver | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
23 | 00842048154662 | 97-47P | 97-47P | Self-Retaining Double Sided Driver, T30 | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
24 | 00842048154655 | 97-40P20 | 97-40P20 | Cervical Plate Awl, 20mm | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
25 | 00842048154648 | 97-40P18 | 97-40P18 | Cervical Plate Awl, 18mm | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
26 | 00842048154631 | 97-40P16 | 97-40P16 | Cervical Plate Awl, 16mm | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
27 | 00842048154624 | 97-40P14 | 97-40P14 | Cervical Plate Awl, 14mm | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
28 | 00842048154617 | 97-40P12 | 97-40P12 | Cervical Plate Awl, 12mm | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
29 | 00842048154600 | 97-40P10 | 97-40P10 | Cervical Plate Awl, 10mm | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
30 | 00842048154594 | 97-38E | 97-38E | Axial Reducer | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
31 | 00842048154587 | 97-37R | 97-37R | Dilator, 12.4mm Single Pass | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
32 | 00842048154570 | 97-36R | 97-36R | Dilator, 12.4mm | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
33 | 00842048154563 | 97-35P | 97-35P | Driver Assembly, Guarded | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
34 | 00842048154556 | 97-34R | 97-34R | Dilator, 13mm | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
35 | 00842048154549 | 97-33M-02 | 97-33M-02 | Ring, 45 | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
36 | 00842048154532 | 97-33M-01 | 97-33M-01 | Ring, 15.7 | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
37 | 00842048154525 | 97-32P | 97-32P | Screw Driver, Cannulated, T25 | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
38 | 00842048154518 | 97-31H | 97-31H | Counter Torque, E3 Half Tab, RA | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
39 | 00842048154501 | 97-30M | 97-30M | Driver Shaft Guard Assy | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
40 | 00842048154495 | 97-28E | 97-28E | Sagittal Bender 5.5mm, Left | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
41 | 00842048154488 | 97-27E | 97-27E | Sagittal Bender 5.5mm, Right | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
42 | 00842048154471 | 97-26P | 97-26P | Self-Retaining Driver T30 Molded Handle | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
43 | 00842048154464 | 97-25S | 97-25S | Anterior Cervical Distractor Forceps | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
44 | 00842048154457 | 97-24P | 97-24P | Self-Retaining Driver, T30 | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
45 | 00842048154440 | 97-23M | 97-23M | Sharp Wanding Blade Assembly | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
46 | 00842048154433 | 97-22M | 97-22M | Head Positioner MIS Half Tab | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
47 | 00842048154426 | 97-21P | 97-21P | Driver, T-30 Stab and Grab Modular | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
48 | 00842048154419 | 97-20P | 97-20P | Screwdriver, Self Retaining Cervical, Solid Cap | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
49 | 00842048154402 | 97-19S-02 | 97-19S-02 | Distractor Screw to Screw, Left | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
50 | 00842048154396 | 97-19S-01 | 97-19S-01 | Distractor Screw to Screw, Right | LXH | Orthopedic manual surgical instrument | 1 | DeGen Standard Instrumentation |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 08057432565746 | ACP-04T526 | ACP | SINTEA PLUSTEK SRL | ||
2 | 08057432565739 | ACP-04T525 | ACP | SINTEA PLUSTEK SRL | ||
3 | 08057432565678 | PLS-49T5300 | PLS | SINTEA PLUSTEK SRL | ||
4 | 08057432565661 | PLS-49T5200 | PLS | SINTEA PLUSTEK SRL | ||
5 | 08057432565654 | PLS-49T5140 | PLS | SINTEA PLUSTEK SRL | ||
6 | 08057432565647 | PLS-49T5130 | PLS | SINTEA PLUSTEK SRL | ||
7 | 08057432565630 | PLS-48T5140 | PLS | SINTEA PLUSTEK SRL | ||
8 | 08057432565623 | PLS-48T5130 | PLS | SINTEA PLUSTEK SRL | ||
9 | 08057432565616 | PLS-48T5090 | PLS | SINTEA PLUSTEK SRL | ||
10 | 08057432565609 | PLS-48T5085 | PLS | SINTEA PLUSTEK SRL | ||
11 | 08057432565593 | PLS-48T5080 | PLS | SINTEA PLUSTEK SRL | ||
12 | 08057432565586 | PLS-48T5075 | PLS | SINTEA PLUSTEK SRL | ||
13 | 08057432565579 | PLS-48T5070 | PLS | SINTEA PLUSTEK SRL | ||
14 | 08057432565562 | PLS-48T5065 | PLS | SINTEA PLUSTEK SRL | ||
15 | 08057432565555 | PLS-48T5060 | PLS | SINTEA PLUSTEK SRL | ||
16 | 08057432565548 | PLS-48T5055 | PLS | SINTEA PLUSTEK SRL | ||
17 | 08057432565531 | PLS-48T5050 | PLS | SINTEA PLUSTEK SRL | ||
18 | 08057432565524 | PLS-48T5045 | PLS | SINTEA PLUSTEK SRL | ||
19 | 08057432565517 | PLS-48T5040 | PLS | SINTEA PLUSTEK SRL | ||
20 | 08057432565500 | PLS-48T5035 | PLS | SINTEA PLUSTEK SRL | ||
21 | 08057432565494 | PLS-48T5030 | PLS | SINTEA PLUSTEK SRL | ||
22 | 08057432565487 | PLS-48CC8 | PLS | SINTEA PLUSTEK SRL | ||
23 | 08057432565470 | PLS-48CC6 | PLS | SINTEA PLUSTEK SRL | ||
24 | 08057432565463 | PLS-48CC5 | PLS | SINTEA PLUSTEK SRL | ||
25 | 08057432565456 | PLS-48CC4 | PLS | SINTEA PLUSTEK SRL | ||
26 | 08057432565449 | PLS-48CC3 | PLS | SINTEA PLUSTEK SRL | ||
27 | 08057432565432 | PLS-48CC2 | PLS | SINTEA PLUSTEK SRL | ||
28 | 08057432565425 | PLS-48CC1 | PLS | SINTEA PLUSTEK SRL | ||
29 | 08057432565418 | PLS-47CC4 | PLS | SINTEA PLUSTEK SRL | ||
30 | 08057432565401 | PLS-47CC3 | PLS | SINTEA PLUSTEK SRL | ||
31 | 08057432565395 | PLS-47CC2 | PLS | SINTEA PLUSTEK SRL | ||
32 | 08057432565388 | PLS-760T58 | https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# | PLS | SINTEA PLUSTEK SRL | |
33 | 08057432565371 | PLS-760T57 | https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# | PLS | SINTEA PLUSTEK SRL | |
34 | 08057432565364 | PLS-760T56 | PLS | SINTEA PLUSTEK SRL | ||
35 | 08057432565357 | PLS-760T55 | https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# | PLS | SINTEA PLUSTEK SRL | |
36 | 08057432565340 | PLS-760T540 | https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# | PLS | SINTEA PLUSTEK SRL | |
37 | 08057432565333 | PLS-755T540 | https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# | PLS | SINTEA PLUSTEK SRL | |
38 | 08057432565326 | PLS-660T58 | https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# | PLS | SINTEA PLUSTEK SRL | |
39 | 08057432565319 | PLS-655T58 | https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# | PLS | SINTEA PLUSTEK SRL | |
40 | 08057432565302 | PLS-650T58 | https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# | PLS | SINTEA PLUSTEK SRL | |
41 | 08057432565296 | PLS-645T58 | https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# | PLS | SINTEA PLUSTEK SRL | |
42 | 08057432565289 | PLS-640T58 | https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# | PLS | SINTEA PLUSTEK SRL | |
43 | 08057432565272 | PLS-635T58 | https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# | PLS | SINTEA PLUSTEK SRL | |
44 | 08057432565265 | PLS-630T58 | https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# | PLS | SINTEA PLUSTEK SRL | |
45 | 08057432565258 | PLS-6100T58 | https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# | PLS | SINTEA PLUSTEK SRL | |
46 | 08057432565241 | PLS-6095T58 | https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# | PLS | SINTEA PLUSTEK SRL | |
47 | 08057432565234 | PLS-6090T58 | https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# | PLS | SINTEA PLUSTEK SRL | |
48 | 08057432565227 | PLS-6085T58 | https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# | PLS | SINTEA PLUSTEK SRL | |
49 | 08057432565210 | PLS-6080T58 | https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# | PLS | SINTEA PLUSTEK SRL | |
50 | 08057432565203 | PLS-6075T58 | https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# | PLS | SINTEA PLUSTEK SRL |