| Primary Device ID | 00889024585249 |
| NIH Device Record Key | 53f0a8e9-fd01-4ed6-a880-43fb2f8b22c8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Off Axis Comp Mini Reamer Gd Sm |
| Version Model Number | SSI005658 |
| Catalog Number | SSI005658 |
| Company DUNS | 129278169 |
| Company Name | Biomet Orthopedics, LLC |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | 1 (800) 343-9500 |
| customerservice@zimmerbiomet.com |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889024585249 [Primary] |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00889024585249]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-02-14 |
| Device Publish Date | 2020-02-06 |
| 00887868004087 - PRIMARY TREPHINE | 2024-04-03 |
| 00887868004094 - BUSHING | 2024-04-03 |
| 00887868004100 - SECONDARY TREPHINE | 2024-04-03 |
| 00887868048272 - TREPHINE | 2024-04-03 |
| 00887868048289 - TREPHINE | 2024-04-03 |
| 00887868048296 - TREPHINE | 2024-04-03 |
| 00887868048302 - TREPHINE | 2024-04-03 |
| 00880304658387 - Compress® | 2024-03-11 |