COMPREHENSIVE® SHOULDER SYSTEM 407312
GUDID 00880304453197
Biomet Orthopedics, LLC
Humeral head prosthesis trial, reusable| Primary Device ID | 00880304453197 |
| NIH Device Record Key | 8c695052-103d-4bb4-a9d0-ad0fdeac417d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | COMPREHENSIVE® SHOULDER SYSTEM |
| Version Model Number | 407312 |
| Catalog Number | 407312 |
| Company DUNS | 129278169 |
| Company Name | Biomet Orthopedics, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00880304453197 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K060692
FDA Product Code
| HWT | TEMPLATE |
| KWT | PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00880304453197]
Moist Heat or Steam Sterilization
[00880304453197]
Moist Heat or Steam Sterilization
[00880304453197]
Moist Heat or Steam Sterilization
[00880304453197]
Moist Heat or Steam Sterilization
[00880304453197]
Moist Heat or Steam Sterilization
[00880304453197]
Moist Heat or Steam Sterilization
[00880304453197]
Moist Heat or Steam Sterilization
[00880304453197]
Moist Heat or Steam Sterilization
[00880304453197]
Moist Heat or Steam Sterilization
[00880304453197]
Moist Heat or Steam Sterilization
[00880304453197]
Moist Heat or Steam Sterilization
[00880304453197]
Moist Heat or Steam Sterilization
[00880304453197]
Moist Heat or Steam Sterilization
[00880304453197]
Moist Heat or Steam Sterilization
[00880304453197]
Moist Heat or Steam Sterilization
[00880304453197]
Moist Heat or Steam Sterilization
[00880304453197]
Moist Heat or Steam Sterilization
[00880304453197]
Moist Heat or Steam Sterilization
[00880304453197]
Moist Heat or Steam Sterilization
[00880304453197]
Moist Heat or Steam Sterilization
[00880304453197]
Moist Heat or Steam Sterilization
[00880304453197]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-02-07 |
| Device Publish Date | 2017-07-28 |
On-Brand Devices [COMPREHENSIVE® SHOULDER SYSTEM]
Trademark Results [COMPREHENSIVE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COMPREHENSIVE 86414094 not registered Dead/Abandoned |
Biomet Manufacturing, LLC 2014-10-03 |
 COMPREHENSIVE 85491284 4287748 Live/Registered |
Vcom International Multimedia Corporation 2011-12-09 |
 COMPREHENSIVE 77522917 3756570 Live/Registered |
Comprehensive Network, Inc. 2008-07-15 |
 COMPREHENSIVE 77293595 3440194 Live/Registered |
VCOM INTERNATIONAL MULTIMEDIA CORPORATION 2007-10-02 |
 COMPREHENSIVE 77293568 3452793 Live/Registered |
VCOM INTERNATIONAL MULTIMEDIA CORPORATION 2007-10-02 |
 COMPREHENSIVE 76251809 2769761 Live/Registered |
Biomet Manufacturing, LLC 2001-04-30 |
 COMPREHENSIVE 73503277 1382628 Dead/Cancelled |
COMPREHENSIVE ACCOUNTING CORPORATION 1984-10-10 |
 COMPREHENSIVE 73213064 1239063 Dead/Cancelled |
Comprehensive Video Supply Corporation 1979-04-25 |
 COMPREHENSIVE 73160158 1114903 Dead/Cancelled |
COMPREHENSIVE ACCOUNTING SERVICE COMPANY 1978-02-27 |
 COMPREHENSIVE 73159000 1114089 Dead/Expired |
COMPREHENSIVE ACCOUNTING SERVICE COMPANY 1978-02-17 |
 COMPREHENSIVE 73088807 1095413 Dead/Expired |
COMPREHENSIVE ACCOUNTING SERVICE COMPANY 1976-05-28 |
 COMPREHENSIVE 73047932 1042473 Dead/Expired |
COMPREHENSIVE ACCOUNTING SERVICE COMPANY 1975-03-27 |
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