No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 30818674021495 | 3910-080-030 | 148083st | GEA | Cannula, Surgical, General & Plastic Surgery | 1 | GATEWAY™ SILICONE CANNULA, 8.0mm X 30mm( 5 units) | |
2 | 30818674026353 | 210252 | 148083m | GEA | Cannula, Surgical, General & Plastic Surgery | 1 | 8 mm Flexible Cannula (5 units) | |
3 | 30818674021532 | 3910-012-040 | 148124st | GEA | Cannula, Surgical, General & Plastic Surgery | 1 | GATEWAY™ SILICONE CANNULA, 12.0mm X 40mm (5 units) | |
4 | 30810190010007 | C | 500100st | MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Knotilus Anchor, 3.5mm | ||
5 | 10818674025796 | 110045155 | 181200bsm | MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 2 | Betta Link LG Knotless Hip IMPLANT ONLY | |
6 | 10818674025789 | 110045149 | 181100bsm | MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 2 | Betta Link SR Knotless Shoulder IMPLANT ONLY | |
7 | 10818674025727 | 234-100-002 | 141200st | MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 2 | ProCinch, Slotted Button, Concave Round 14mm | |
8 | 10818674025000 | 210205 | 514323m | LXH | Orthopedic Manual Surgical Instrument | 1 | VERSALOOP™ Obturator for 1.5mm Anchor | |
9 | 10818674024935 | 210195 | 514374m | LXH | Orthopedic Manual Surgical Instrument | 1 | VERSALOOP™ 12.5° Guide for 1.5mm Anchor, Sawtooth | |
10 | 10818674024928 | 210207 | 514310m | HWJ | Awl | 1 | VERSALOOP™ 2.5mm Reusable Awl | |
11 | 10818674024898 | 210182 | 514332m | HTO | Reamer | 1 | VERSALOOP™ 1.8mm Reusable Straight Drill | |
12 | 10818674024881 | 210181 | 514331m | HTO | Reamer | 1 | VERSALOOP™ 1.5mm Reusable Straight Drill | |
13 | 10818674024812 | 210171 | 514025TSm | MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 2 | VERSALOOP™ Anchor 3 Suture, 2.5mm | |
14 | 10818674022528 | 0234-109-203 | 151000st | LXH | Orthopedic Manual Surgical Instrument | 1 | Bullet Sleeve, 2.4mm | |
15 | 10818674022504 | 0234-109-201 | 149000st | LXH | Orthopedic Manual Surgical Instrument | 1 | Stepped Bullet, 4.5mm | |
16 | 10818674022450 | 0234-109-240 | 148400st | LXH | Orthopedic Manual Surgical Instrument | 1 | PCL Femoral Arm | |
17 | 10818674021286 | 214142 | 904441m | LXH | Orthopedic Manual Surgical Instrument | 1 | Hip Curette 20 Bent | |
18 | 10818674021231 | 214151 | 754430m | LXH | Orthopedic Manual Surgical Instrument | 1 | Handle, Hip Cannulated Switching Stick | |
19 | 10818674021194 | 214139 | 727400m | LXH | Orthopedic Manual Surgical Instrument | 1 | Hip Biter Straight | |
20 | 10818674021187 | 214154 | 754440fm | LXH | Orthopedic Manual Surgical Instrument | 1 | 4.5 Hip Cannulated SwitchStick | |
21 | 10818674021125 | 214144 | 391411m | LXH | Orthopedic Manual Surgical Instrument | 1 | Hip Grasper 20 Right | |
22 | 10818674021118 | 214147 | 391400m | LXH | Orthopedic Manual Surgical Instrument | 1 | Hip Grasper Straight | |
23 | 10818674020470 | A | 641420bsm | LXH | Orthopedic Manual Surgical Instrument | 1 | Hip Access System with Blunt Blade | |
24 | 10818674020463 | A | 641410bsm | LXH | Orthopedic Manual Surgical Instrument | 1 | Hip Access System | |
25 | 10818674020432 | C | TK1-0027 | DZN | Instruments, Dental Hand | 1 | Holder Key 1.28mm | |
26 | 10818674020425 | C | TK1-0026 | DZN | Instruments, Dental Hand | 1 | 1/4" Abutment Fixture Short | |
27 | 10818674020401 | C | TK1-0024 | DZN | Instruments, Dental Hand | 1 | Extension for 1/4" Holder | |
28 | 10818674020364 | C | TK1-SD-3 | DZN | Instruments, Dental Hand | 1 | Screw Driver 1.28mm Short - Pin | |
29 | 10818674020333 | C | TK1-RK-2 | DZN | Instruments, Dental Hand | 1 | 2.42 Retriever Screw | |
30 | 10818674020296 | C | TK1-0020 | DZN | Instruments, Dental Hand | 1 | Abutment Extractor Key | |
31 | 10818674020289 | C | TK1-0019 | DZN | Instruments, Dental Hand | 1 | 2.42 Retriever | |
32 | 10810190019921 | C | TD2-0064 | DZN | Instruments, Dental Hand | 1 | Drill stopper ø5.0mm L 11.5 | |
33 | 10810190019860 | C | TD2-0058 | DZN | Instruments, Dental Hand | 1 | Drill stopper ø2.0mm L 11.5 | |
34 | 10810190019778 | C | TD2-0049 | DZN | Instruments, Dental Hand | 1 | Drill stopper ø5.5mm L 8 | |
35 | 10810190019587 | C | TD1-0030 | DZN | Instruments, Dental Hand | 1 | Drill Extender | |
36 | 10810190019570 | C | TD1-0024 | DZA | Drill, Dental, Intraoral | 1 | Conical Drill for implant ø6mm | |
37 | 10810190019563 | C | TD1-0023 | DZA | Drill, Dental, Intraoral | 1 | Conical Drill for implant ø5mm | |
38 | 10810190019518 | C | TD1-0018 | DZA | Drill, Dental, Intraoral | 1 | Short Drill ø5.50mm External Irrigation | |
39 | 10810190019433 | C | TD1-0010 | DZA | Drill, Dental, Intraoral | 1 | Drill ø5.50mm External Irrigation | |
40 | 10810190019426 | C | TD1-0009 | DZA | Drill, Dental, Intraoral | 1 | Drill ø5mm External Irrigation | |
41 | 10810190019365 | C | TD1-0003 | DZA | Drill, Dental, Intraoral | 1 | Pilot Drill ø2mm External Irrigation | |
42 | 10810190019358 | C | TD1-0002 | DZA | Drill, Dental, Intraoral | 1 | Marking Drill ø1.90mm | |
43 | 10810190019327 | C | PP1-0008 | DZN | Instruments, Dental Hand | 1 | Screw For Close tray Transfer 3.75mm | |
44 | 10810190019303 | C | PP1-0005 | DZN | Instruments, Dental Hand | 1 | Open tray Transfer 3.75mm Platform | |
45 | 10810190019259 | C | PO1-0033 | DZN | Instruments, Dental Hand | 1 | Multi-Unit Impression Coping Close tray | |
46 | 10810190019228 | C | PO1-0021 | DZN | Instruments, Dental Hand | 1 | Multi-Unit Abutment Analog | |
47 | 10810190019174 | C | KT1-0004 | DZN | Instruments, Dental Hand | 1 | Universal Holder Kit | |
48 | 10810190019167 | C | KT1-0003 | DZN | Instruments, Dental Hand | 1 | Pixel Kit | |
49 | 10810190019150 | C | KT1-0002 | DZN | Instruments, Dental Hand | 1 | Compact Massif Surgical Kit | |
50 | 10810190018900 | A | CCA-0007 | NHA | Abutment, Implant, Dental, Endosseous | 2 | CAD/CAM Burnout Narrow |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00840180507179 | CI-10866 | Iliac Crest Graft Punch | General Instrument | ALPHATEC SPINE, INC. | |
2 | 00840105220015 | Z-6527 | Mucotomy Bur 5.0mm | ZOLL-DENTAL | ZOLL-DENTAL | |
3 | 00840105220008 | Z-6526 | Mucotomy Bur 4.0mm | ZOLL-DENTAL | ZOLL-DENTAL | |
4 | 00840105219996 | Z-6525 | Mucotomy Bur 3.5mm | ZOLL-DENTAL | ZOLL-DENTAL | |
5 | 00840105219989 | Z-6524 | Trephine Bur 9.5mm | ZOLL-DENTAL | ZOLL-DENTAL | |
6 | 00840105219972 | Z-6523 | Trephine Bur 7.5mm | ZOLL-DENTAL | ZOLL-DENTAL | |
7 | 00840105219965 | Z-6522 | Trephine Bur 4.5mm | ZOLL-DENTAL | ZOLL-DENTAL | |
8 | 00840105219958 | Z-6521 | Trephine Bur 2.5mm | ZOLL-DENTAL | ZOLL-DENTAL | |
9 | 00840105219941 | Z-6520 | Trephine Bur 6.5mm | ZOLL-DENTAL | ZOLL-DENTAL | |
10 | 00840105219934 | Z-6519 | Trephine Bur 5.5mm | ZOLL-DENTAL | ZOLL-DENTAL | |
11 | 00840105219927 | Z-6518 | Trephine Bur 4.0mm | ZOLL-DENTAL | ZOLL-DENTAL | |
12 | 00840105219910 | Z-6517 | Trephine Bur 10.0mm | ZOLL-DENTAL | ZOLL-DENTAL | |
13 | 00840105219903 | Z-6516 | Trephine Bur 9.0mm | ZOLL-DENTAL | ZOLL-DENTAL | |
14 | 00840105219897 | Z-6515 | Trephine Bur 8.5mm | ZOLL-DENTAL | ZOLL-DENTAL | |
15 | 00840105219880 | Z-6514 | Trephine Bur 8.0mm | ZOLL-DENTAL | ZOLL-DENTAL | |
16 | 00840105219873 | Z-6513 | Trephine Bur 7.0mm | ZOLL-DENTAL | ZOLL-DENTAL | |
17 | 00840105219866 | Z-6512 | Trephine Bur 6.0mm | ZOLL-DENTAL | ZOLL-DENTAL | |
18 | 00840105219859 | Z-6511 | Trephine Bur 5.0mm | ZOLL-DENTAL | ZOLL-DENTAL | |
19 | 00840105219842 | Z-6510 | Trephine Bur 3.5mm | ZOLL-DENTAL | ZOLL-DENTAL | |
20 | 00840105219835 | Z-6509 | Trephine Bur 3.0mm | ZOLL-DENTAL | ZOLL-DENTAL | |
21 | 00840105219828 | Z-6508 | Trephine Bur 2.0mm | ZOLL-DENTAL | ZOLL-DENTAL | |
22 | 00812337021265 | 58160-20 | Single-use disposable orthopedic manual surgical instrument set | ProChondrix® Instrument Set | DSM BIOMEDICAL, INC. | |
23 | 00812337021258 | 58160-17 | Single-use disposable orthopedic manual surgical instrument set | ProChondrix® Instrument Set | DSM BIOMEDICAL, INC. | |
24 | 00812337021241 | 58160-15 | Single-use disposable orthopedic manual surgical instrument set | ProChondrix® Instrument Set | DSM BIOMEDICAL, INC. | |
25 | 00812337021234 | 58160-13 | Single-use disposable orthopedic manual surgical instrument set | ProChondrix® Instrument Set | DSM BIOMEDICAL, INC. | |
26 | 00812337021227 | 58160-11 | Single-use disposable orthopedic manual surgical instrument set | ProChondrix® Instrument Set | DSM BIOMEDICAL, INC. | |
27 | 00812337021210 | 58160-09 | Single-use disposable orthopedic manual surgical instrument set | ProChondrix® Instrument Set | DSM BIOMEDICAL, INC. | |
28 | 00812337021203 | 58160-07 | Single-use disposable orthopedic manual surgical instrument sets | ProChondrix® Instrument Set | DSM BIOMEDICAL, INC. | |
29 | 00811954012694 | 6008 | 6008 | 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=523872# | 2.7mm Trephine Removal | INTERVENTIONAL SPINE, INC |
30 | 00810019931215 | 925-0405 | 925-0405 | BIT, TREPHINE 8.0MM 1/4 SQ | Bradshaw Medical Inc. | BRADSHAW MEDICAL, INC. |
31 | 00810019931208 | 925-0404 | 925-0404 | BIT, TREPHINE 7.0MM 1/4 SQ | Bradshaw Medical Inc. | BRADSHAW MEDICAL, INC. |
32 | 00810019931192 | 925-0403 | 925-0403 | BIT, TREPHINE 6.0MM 1/4 SQ | Bradshaw Medical Inc. | BRADSHAW MEDICAL, INC. |
33 | 00810019931185 | 925-0402 | 925-0402 | BIT, TREPHINE 5.0MM 1/4 SQ | Bradshaw Medical Inc. | BRADSHAW MEDICAL, INC. |
34 | 00810019931178 | 925-0401 | 925-0401 | BIT, TREPHINE 4.0MM 1/4 SQ | Bradshaw Medical Inc. | BRADSHAW MEDICAL, INC. |
35 | 00810019930331 | 920-0408 | 920-0408 | BIT, TREPHINE 7.0MM AO | Bradshaw Medical Inc. | BRADSHAW MEDICAL, INC. |
36 | 00810019930324 | 920-0407 | 920-0407 | BIT, TREPHINE 6.0MM AO | Bradshaw Medical Inc. | BRADSHAW MEDICAL, INC. |
37 | 00810019930317 | 920-0406 | 920-0406 | BIT, TREPHINE 5.0MM AO | Bradshaw Medical Inc. | BRADSHAW MEDICAL, INC. |
38 | 00810019930300 | 920-0405 | 920-0405 | BIT, TREPHINE 4.5MM AO | Bradshaw Medical Inc. | BRADSHAW MEDICAL, INC. |
39 | 00810019930294 | 920-0404 | 920-0404 | BIT, TREPHINE 4.0MM AO | Bradshaw Medical Inc. | BRADSHAW MEDICAL, INC. |
40 | 00810019930287 | 920-0403 | 920-0403 | BIT, TREPHINE 3.5MM AO | Bradshaw Medical Inc. | BRADSHAW MEDICAL, INC. |
41 | 00810019930270 | 920-0402 | 920-0402 | BIT, TREPHINE 3.0MM AO | Bradshaw Medical Inc. | BRADSHAW MEDICAL, INC. |
42 | 00810019930263 | 920-0401 | 920-0401 | BIT, TREPHINE 2.5MM AO | Bradshaw Medical Inc. | BRADSHAW MEDICAL, INC. |
43 | 00763000078942 | EX0817013 | TREPHINE EX0817013 | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | |
44 | 00721902949388 | Y8087780 | 8.0MM BONE SCREW TREPHINE | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | |
45 | 00721902949371 | Y8087775 | 7.5MM BONE SCREW TREPHINE | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | |
46 | 00721902949364 | Y8087770 | 7.0MM BONE SCREW TREPHINE | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | |
47 | 00721902949340 | Y8087760 | 6.0MM BONE SCREW TREPHINE | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | |
48 | 00721902949333 | Y8087755 | 5.5MM BONE SCREW TREPHINE | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | |
49 | 00721902949319 | Y8087750 | 5.0MM BONE SCREW TREPHINE | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | |
50 | 00721902949302 | Y8087745 | 4.5MM BONE SCREW TREPHINE | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. |