VANGUARD 32-488057
GUDID 00880304495586
Biomet Orthopedics, LLC
Surgical implant template, reusable| Primary Device ID | 00880304495586 |
| NIH Device Record Key | fbfd0ccf-8f5d-4a02-a542-33d2a5ab0e04 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VANGUARD |
| Version Model Number | 32-488057 |
| Catalog Number | 32-488057 |
| 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
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com |
Device Dimensions
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00880304495586 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K093293
FDA Product Code
| MBV | Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00880304495586]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-22 |
On-Brand Devices [VANGUARD]
Trademark Results [VANGUARD]
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