| Primary Device ID | 00850005827344 |
| NIH Device Record Key | f2f4e520-fc30-44c5-86c7-695e163b67f0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GENESIS DRILL GUIDE |
| Version Model Number | 40DG0031 |
| Catalog Number | 40DG0031 |
| Company DUNS | 016463487 |
| Company Name | Genesis Biologics, Inc. |
| 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 | false |
| 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 | 00850005827344 [Primary] |
| FZX | Guide, Surgical, Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00850005827344]
Moist Heat or Steam Sterilization
[00850005827344]
Moist Heat or Steam Sterilization
[00850005827344]
Moist Heat or Steam Sterilization
[00850005827344]
Moist Heat or Steam Sterilization
[00850005827344]
Moist Heat or Steam Sterilization
[00850005827344]
Moist Heat or Steam Sterilization
[00850005827344]
Moist Heat or Steam Sterilization
[00850005827344]
Moist Heat or Steam Sterilization
[00850005827344]
Moist Heat or Steam Sterilization
[00850005827344]
Moist Heat or Steam Sterilization
[00850005827344]
Moist Heat or Steam Sterilization
[00850005827344]
Moist Heat or Steam Sterilization
[00850005827344]
Moist Heat or Steam Sterilization
[00850005827344]
Moist Heat or Steam Sterilization
[00850005827344]
Moist Heat or Steam Sterilization
[00850005827344]
Moist Heat or Steam Sterilization
[00850005827344]
Moist Heat or Steam Sterilization
[00850005827344]
Moist Heat or Steam Sterilization
[00850005827344]
Moist Heat or Steam Sterilization
[00850005827344]
Moist Heat or Steam Sterilization
[00850005827344]
Moist Heat or Steam Sterilization
[00850005827344]
Moist Heat or Steam Sterilization
[00850005827344]
Moist Heat or Steam Sterilization
[00850005827344]
Moist Heat or Steam Sterilization
[00850005827344]
Moist Heat or Steam Sterilization
[00850005827344]
Moist Heat or Steam Sterilization
[00850005827344]
Moist Heat or Steam Sterilization
[00850005827344]
Moist Heat or Steam Sterilization
[00850005827344]
Moist Heat or Steam Sterilization
[00850005827344]
Moist Heat or Steam Sterilization
[00850005827344]
Moist Heat or Steam Sterilization
[00850005827344]
Moist Heat or Steam Sterilization
[00850005827344]
Moist Heat or Steam Sterilization
[00850005827344]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-03-24 |
| Device Publish Date | 2023-03-16 |
| 00850005827368 - AlternatiV+ Screw-In Anchor | 2024-10-16 4.75MM SCREW-IN SUTURE ANCHOR |
| 00850005827375 - AlternatiV+ Screw-In Anchor | 2024-10-16 5.5MM SCREW-IN SUTURE ANCHOR |
| 00850005827382 - AlternatiV+ Max Knotless Anchor | 2024-10-16 4.75MM MAX KNOTLESS ANCHOR |
| 00850005827399 - DUAL PITCH AWL/TAPPER 4.75MM | 2024-10-16 DUAL PITCH AWL/TAPPER 4.75MM |
| 00850005827405 - DUAL PITCH AWL/TAPPER 5.5MM | 2024-10-16 DUAL PITCH AWL/TAPPER 5.5MM |
| 00850005827412 - AWL/TAPPER 4.5MM | 2024-10-16 AWL/TAPPER 4.5MM |
| 00850005827429 - AWL 4.5MM | 2024-10-16 AWL 4.5MM |
| 00850005827436 - AWL 5.5MM | 2024-10-16 AWL 5.5MM |