Vanguard SSI001048
GUDID 00889024576773
Biomet Orthopedics, LLC
Knee femur prosthesis trial| Primary Device ID | 00889024576773 |
| NIH Device Record Key | ed95e1f1-7c62-4cbe-86af-f9824167174a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Vanguard |
| Version Model Number | SSI001048 |
| Catalog Number | SSI001048 |
| 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 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 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 | 00889024576773 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K113550
FDA Product Code
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00889024576773]
Moist Heat or Steam Sterilization
[00889024576773]
Moist Heat or Steam Sterilization
[00889024576773]
Moist Heat or Steam Sterilization
[00889024576773]
Moist Heat or Steam Sterilization
[00889024576773]
Moist Heat or Steam Sterilization
[00889024576773]
Moist Heat or Steam Sterilization
[00889024576773]
Moist Heat or Steam Sterilization
[00889024576773]
Moist Heat or Steam Sterilization
[00889024576773]
Moist Heat or Steam Sterilization
[00889024576773]
Moist Heat or Steam Sterilization
[00889024576773]
Moist Heat or Steam Sterilization
[00889024576773]
Moist Heat or Steam Sterilization
[00889024576773]
Moist Heat or Steam Sterilization
[00889024576773]
Moist Heat or Steam Sterilization
[00889024576773]
Moist Heat or Steam Sterilization
[00889024576773]
Moist Heat or Steam Sterilization
[00889024576773]
Moist Heat or Steam Sterilization
[00889024576773]
Moist Heat or Steam Sterilization
[00889024576773]
Moist Heat or Steam Sterilization
[00889024576773]
Moist Heat or Steam Sterilization
[00889024576773]
Moist Heat or Steam Sterilization
[00889024576773]
Moist Heat or Steam Sterilization
[00889024576773]
Moist Heat or Steam Sterilization
[00889024576773]
Moist Heat or Steam Sterilization
[00889024576773]
Moist Heat or Steam Sterilization
[00889024576773]
Moist Heat or Steam Sterilization
[00889024576773]
Moist Heat or Steam Sterilization
[00889024576773]
Moist Heat or Steam Sterilization
[00889024576773]
Moist Heat or Steam Sterilization
[00889024576773]
Moist Heat or Steam Sterilization
[00889024576773]
Moist Heat or Steam Sterilization
[00889024576773]
Moist Heat or Steam Sterilization
[00889024576773]
Moist Heat or Steam Sterilization
[00889024576773]
Moist Heat or Steam Sterilization
[00889024576773]
Moist Heat or Steam Sterilization
[00889024576773]
Moist Heat or Steam Sterilization
[00889024576773]
Moist Heat or Steam Sterilization
[00889024576773]
Moist Heat or Steam Sterilization
[00889024576773]
Moist Heat or Steam Sterilization
[00889024576773]
Moist Heat or Steam Sterilization
[00889024576773]
Moist Heat or Steam Sterilization
[00889024576773]
Moist Heat or Steam Sterilization
[00889024576773]
Moist Heat or Steam Sterilization
[00889024576773]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-07-01 |
| Device Publish Date | 2019-06-21 |
On-Brand Devices [Vanguard]
Trademark Results [Vanguard]
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