PREMIER 32-487261
GUDID 00880304434721
Biomet Orthopedics, LLC
Knee tibia prosthesis trial| Primary Device ID | 00880304434721 |
| NIH Device Record Key | 69faeecf-b105-4a19-a1d3-c2174564c853 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PREMIER |
| Version Model Number | 32-487261 |
| Catalog Number | 32-487261 |
| 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 |
Customer Support Contacts
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00880304434721 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K142933
FDA Product Code
| JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00880304434721]
Moist Heat or Steam Sterilization
[00880304434721]
Moist Heat or Steam Sterilization
[00880304434721]
Moist Heat or Steam Sterilization
[00880304434721]
Moist Heat or Steam Sterilization
[00880304434721]
Moist Heat or Steam Sterilization
[00880304434721]
Moist Heat or Steam Sterilization
[00880304434721]
Moist Heat or Steam Sterilization
[00880304434721]
Moist Heat or Steam Sterilization
[00880304434721]
Moist Heat or Steam Sterilization
[00880304434721]
Moist Heat or Steam Sterilization
[00880304434721]
Moist Heat or Steam Sterilization
[00880304434721]
Moist Heat or Steam Sterilization
[00880304434721]
Moist Heat or Steam Sterilization
[00880304434721]
Moist Heat or Steam Sterilization
[00880304434721]
Moist Heat or Steam Sterilization
[00880304434721]
Moist Heat or Steam Sterilization
[00880304434721]
Moist Heat or Steam Sterilization
[00880304434721]
Moist Heat or Steam Sterilization
[00880304434721]
Moist Heat or Steam Sterilization
[00880304434721]
Moist Heat or Steam Sterilization
[00880304434721]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-02-07 |
| Device Publish Date | 2016-09-22 |
On-Brand Devices [PREMIER]
| 00880304465497 | 32-484638 |
| 00880304464902 | 32-484637 |
| 00880304434776 | 32-487267 |
| 00880304434745 | 32-487262 |
| 00880304434721 | 32-487261 |
| 00880304434707 | 32-487263 |
| 00880304434677 | 32-487265 |
| 00880304434660 | 32-487268 |
| 00880304434653 | 32-487260 |
| 00880304434622 | 32-487264 |
| 00880304434608 | 32-487266 |
Trademark Results [PREMIER]
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