| Primary Device ID | 70880304360012 |
| NIH Device Record Key | e2ef2808-3edb-4b7a-ac7f-1672a6941d60 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TWIST DRILL |
| Version Model Number | 35-463011 |
| Catalog Number | 35-463011 |
| Company DUNS | 129278169 |
| Company Name | Biomet Orthopedics, LLC |
| Device Count | 6 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00880304360013 [Primary] |
| GS1 | 70880304360012 [Unit of Use] |
| HTW | BIT, DRILL |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[70880304360012]
Moist Heat or Steam Sterilization
[70880304360012]
Moist Heat or Steam Sterilization
[70880304360012]
Moist Heat or Steam Sterilization
[70880304360012]
Moist Heat or Steam Sterilization
[70880304360012]
Moist Heat or Steam Sterilization
[70880304360012]
Moist Heat or Steam Sterilization
[70880304360012]
Moist Heat or Steam Sterilization
[70880304360012]
Moist Heat or Steam Sterilization
[70880304360012]
Moist Heat or Steam Sterilization
[70880304360012]
Moist Heat or Steam Sterilization
[70880304360012]
Moist Heat or Steam Sterilization
[70880304360012]
Moist Heat or Steam Sterilization
[70880304360012]
Moist Heat or Steam Sterilization
[70880304360012]
Moist Heat or Steam Sterilization
[70880304360012]
Moist Heat or Steam Sterilization
[70880304360012]
Moist Heat or Steam Sterilization
[70880304360012]
Moist Heat or Steam Sterilization
[70880304360012]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-08 |
| Device Publish Date | 2020-06-30 |
| 00880304409842 | 908406 |
| 00880304382770 | 471137 |
| 00887868017650 | 1801-24-000 |
| 00887868017643 | 1801-23-000 |
| 00887868017636 | 1801-22-000 |
| 00887868017629 | 1801-20-000 |
| 00887868017612 | 1801-18-000 |
| 00887868017605 | 1801-16-000 |
| 00887868017599 | 1801-14-000 |
| 00887868017582 | 1801-12-000 |
| 00887868017575 | 1801-10-000 |
| 00887868017568 | 1800-24-000 |
| 00887868017551 | 1800-23-000 |
| 00887868017544 | 1800-22-000 |
| 00887868017537 | 1800-20-000 |
| 00887868017520 | 1800-18-000 |
| 00887868017513 | 1800-16-000 |
| 00887868017506 | 1800-14-000 |
| 00887868017490 | 1800-12-000 |
| 00887868017483 | 1800-10-000 |
| 00887868002816 | 14621 |
| 00887868000294 | 1253 |
| 00887868047824 | 8200-40-000 |
| 00888480336969 | 472256 |
| 70880304360012 | 35-463011 |
| 70880304359993 | 35-463009 |
| 70880304359887 | 35-462808 |
| 00887868511356 | 908406 |