| Primary Device ID | 00850004435038 |
| NIH Device Record Key | 659e1bf3-2dbb-4032-baf6-7324d01c1d30 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OsteoFab Suture Anchor |
| Version Model Number | INS002-01-003 |
| Company DUNS | 962301359 |
| Company Name | OXFORD PERFORMANCE MATERIALS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| OTC Over-The-Counter | true |
| Phone | 1-860-698-9300 |
| CustomerService@oxfordpm.com | |
| Phone | 1-860-698-9300 |
| CustomerService@oxfordpm.com | |
| Phone | 1-860-698-9300 |
| CustomerService@oxfordpm.com | |
| Phone | 1-860-698-9300 |
| CustomerService@oxfordpm.com | |
| Phone | 1-860-698-9300 |
| CustomerService@oxfordpm.com | |
| Phone | 1-860-698-9300 |
| CustomerService@oxfordpm.com | |
| Phone | 1-860-698-9300 |
| CustomerService@oxfordpm.com | |
| Phone | 1-860-698-9300 |
| CustomerService@oxfordpm.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850004435038 [Primary] |
| HWJ | Awl |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00850004435038]
Moist Heat or Steam Sterilization
[00850004435038]
Moist Heat or Steam Sterilization
[00850004435038]
Moist Heat or Steam Sterilization
[00850004435038]
Moist Heat or Steam Sterilization
[00850004435038]
Moist Heat or Steam Sterilization
[00850004435038]
Moist Heat or Steam Sterilization
[00850004435038]
Moist Heat or Steam Sterilization
[00850004435038]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-01-24 |
| Device Publish Date | 2020-01-16 |
| 00850004435069 | OsteoFab 6.5mm Suture Anchor |
| 00850004435052 | OsteoFab 5.5mm Suture Anchor |
| 00850004435045 | OsteoFab 4.5mm Suture Anchor |
| 00850004435038 | 4mm OsteoFab Suture Anchor Awl |
| 00850004435021 | 3mm OsteoFab Suture Anchor Awl |
| 00850004435014 | 2mm OsteoFab Suture Anchor Awl |
| 00850004435007 | OsteoFab Suture Anchor Inserter |