Vanguard® 360 Instrument 32-360617
GUDID 00887868564000
Biomet Orthopedics, LLC
Medullary canal orthopaedic reamer, rigid Medullary canal orthopaedic reamer, rigid Medullary canal orthopaedic reamer, rigid Medullary canal orthopaedic reamer, rigid Medullary canal orthopaedic reamer, rigid Medullary canal orthopaedic reamer, rigid Medullary canal orthopaedic reamer, rigid Medullary canal orthopaedic reamer, rigid Medullary canal orthopaedic reamer, rigid Medullary canal orthopaedic reamer, rigid Medullary canal orthopaedic reamer, rigid Medullary canal orthopaedic reamer, rigid Medullary canal orthopaedic reamer, rigid Medullary canal orthopaedic reamer, rigid Medullary canal orthopaedic reamer, rigid Medullary canal orthopaedic reamer, rigid Medullary canal orthopaedic reamer, rigid Medullary canal orthopaedic reamer, rigid| Primary Device ID | 00887868564000 |
| NIH Device Record Key | 1885628d-88ad-467d-b4fe-061a46f057ba |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Vanguard® 360 Instrument |
| Version Model Number | 32-360617 |
| Catalog Number | 32-360617 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00887868564000 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K093293
FDA Product Code
| JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00887868564000]
Moist Heat or Steam Sterilization
[00887868564000]
Moist Heat or Steam Sterilization
[00887868564000]
Moist Heat or Steam Sterilization
[00887868564000]
Moist Heat or Steam Sterilization
[00887868564000]
Moist Heat or Steam Sterilization
[00887868564000]
Moist Heat or Steam Sterilization
[00887868564000]
Moist Heat or Steam Sterilization
[00887868564000]
Moist Heat or Steam Sterilization
[00887868564000]
Moist Heat or Steam Sterilization
[00887868564000]
Moist Heat or Steam Sterilization
[00887868564000]
Moist Heat or Steam Sterilization
[00887868564000]
Moist Heat or Steam Sterilization
[00887868564000]
Moist Heat or Steam Sterilization
[00887868564000]
Moist Heat or Steam Sterilization
[00887868564000]
Moist Heat or Steam Sterilization
[00887868564000]
Moist Heat or Steam Sterilization
[00887868564000]
Moist Heat or Steam Sterilization
[00887868564000]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-13 |
| Device Publish Date | 2023-07-05 |
On-Brand Devices [Vanguard® 360 Instrument]
Trademark Results [Vanguard]
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