| Primary Device ID | 00880304372931 |
| NIH Device Record Key | 1f5efd23-86d5-4591-b68f-4fc1395f2ea9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ULTRA-DRIVE TOOL |
| Version Model Number | 423837 |
| Catalog Number | 423837 |
| Company DUNS | 129278169 |
| Company Name | Biomet Orthopedics, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00880304372931 [Primary] |
| HXC | WRENCH |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00880304372931]
Moist Heat or Steam Sterilization
[00880304372931]
Moist Heat or Steam Sterilization
[00880304372931]
Moist Heat or Steam Sterilization
[00880304372931]
Moist Heat or Steam Sterilization
[00880304372931]
Moist Heat or Steam Sterilization
[00880304372931]
Moist Heat or Steam Sterilization
[00880304372931]
Moist Heat or Steam Sterilization
[00880304372931]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-05-08 |
| Device Publish Date | 2017-07-28 |
| 00880304373099 | 13MM HELICAL DRIVE |
| 00880304373082 | 11MM HELICAL DRIVE |
| 00880304373075 | 423923 |
| 00880304373068 | 5.0 MM HELICAL DRIVE |
| 00880304373051 | 423881 |
| 00880304373020 | 8 MM GOUGE |
| 00880304372979 | 5 MM HOE |
| 00880304372931 | 423837 |
| 00880304372894 | 7 DEGREE 180 MM MALE/FEMALE |
| 00880304372887 | 5 DEGREE 180 MM MALE/FEMALE |
| 00880304372870 | 3 DEGREE 180 MM MALE/FEMALE |
| 00880304009905 | 423883 |
| 00880304008380 | 7 MM, LONG POROUS GOUGE |
| 00880304006683 | 423819 |
| 00880304005563 | 6MM PLUG PULLER |
| 00880304005549 | 6 MM, LONG CURVED OSTEOTOME |
| 00880304005525 | 9.5MM HELICAL DRIVE |
| 00880304004887 | 120 MM TIP EXTENDER |
| 00880304004009 | 9.5 MM DISK DRILL |
| 00880304003316 | 180 MM TIP EXTENDER |
| 00880304003309 | 180 MM MALE/FEMALE EXTENDER |
| 00880304001855 | 423873 |
| 00880304000933 | 4MM HELICAL DRIVE |
| 00880304000711 | 6 MM LONG STRAIGHT OSTEOTOME |
| 00880304000704 | 60 MM TIP EXTENDER |
| 00880304000698 | 56 MM X 85 DEGREE ACETABULAR GOUGE |
| 00880304000469 | 5 MM REVERSE CURETTE |
| 00880304000452 | 7MM DISK DRILL |
| 00880304000247 | 9.5 MM SHORT OSTEOTOME |