| Primary Device ID | 00880304437753 |
| NIH Device Record Key | e80f2080-72e1-411d-91de-ce2a97857a5e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VANGUARD(TM) |
| Version Model Number | 32-486535 |
| Catalog Number | 32-486535 |
| 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)348-9500 |
| customerservice@zimmerbiomet.com |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00880304437753 [Primary] |
| MBV | Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00880304437753]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-11-22 |
| Device Publish Date | 2017-07-28 |