Comprehensive® Revision Shoulder System 407354
GUDID 00887868506024
Biomet Orthopedics, LLC
Humeral stem prosthesis trial Humeral stem prosthesis trial Humeral stem prosthesis trial Humeral stem prosthesis trial Humeral stem prosthesis trial Humeral stem prosthesis trial Humeral stem prosthesis trial Humeral stem prosthesis trial Humeral stem prosthesis trial Humeral stem prosthesis trial Humeral stem prosthesis trial Humeral stem prosthesis trial Humeral stem prosthesis trial Humeral stem prosthesis trial Humeral stem prosthesis trial Humeral stem prosthesis trial, reusable Humeral stem prosthesis trial, reusable Humeral stem prosthesis trial, reusable Humeral stem prosthesis trial, reusable Humeral stem prosthesis trial, reusable Humeral stem prosthesis trial, reusable Humeral stem prosthesis trial, reusable Humeral stem prosthesis trial, reusable| Primary Device ID | 00887868506024 |
| NIH Device Record Key | fcc358b2-6160-42fa-8987-d5df838b9489 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Comprehensive® Revision Shoulder System |
| Version Model Number | 407354 |
| Catalog Number | 407354 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00887868506024 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K060692
FDA Product Code
| HSD | PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00887868506024]
Moist Heat or Steam Sterilization
[00887868506024]
Moist Heat or Steam Sterilization
[00887868506024]
Moist Heat or Steam Sterilization
[00887868506024]
Moist Heat or Steam Sterilization
[00887868506024]
Moist Heat or Steam Sterilization
[00887868506024]
Moist Heat or Steam Sterilization
[00887868506024]
Moist Heat or Steam Sterilization
[00887868506024]
Moist Heat or Steam Sterilization
[00887868506024]
Moist Heat or Steam Sterilization
[00887868506024]
Moist Heat or Steam Sterilization
[00887868506024]
Moist Heat or Steam Sterilization
[00887868506024]
Moist Heat or Steam Sterilization
[00887868506024]
Moist Heat or Steam Sterilization
[00887868506024]
Moist Heat or Steam Sterilization
[00887868506024]
Moist Heat or Steam Sterilization
[00887868506024]
Moist Heat or Steam Sterilization
[00887868506024]
Moist Heat or Steam Sterilization
[00887868506024]
Moist Heat or Steam Sterilization
[00887868506024]
Moist Heat or Steam Sterilization
[00887868506024]
Moist Heat or Steam Sterilization
[00887868506024]
Moist Heat or Steam Sterilization
[00887868506024]
Moist Heat or Steam Sterilization
[00887868506024]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-02 |
| Device Publish Date | 2022-04-23 |
On-Brand Devices [Comprehensive® Revision Shoulder System]
| 00887868506024 | 407354 |
| 00887868506017 | 407352 |
| 00887868506000 | 407350 |
| 00887868505997 | 407348 |
| 00887868505973 | 407344 |
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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.