Versa-Dial® Comprehensive® Shoulder System 407201
GUDID 00887868505478
Biomet Orthopedics, LLC
Orthopaedic implant/instrument adaptor, reusable| Primary Device ID | 00887868505478 |
| NIH Device Record Key | 6a27fcb6-6bd7-44dd-9509-51057134eecb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Versa-Dial® Comprehensive® Shoulder System |
| Version Model Number | 407201 |
| Catalog Number | 407201 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00887868505478 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K060716
FDA Product Code
| KWT | PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00887868505478]
Moist Heat or Steam Sterilization
[00887868505478]
Moist Heat or Steam Sterilization
[00887868505478]
Moist Heat or Steam Sterilization
[00887868505478]
Moist Heat or Steam Sterilization
[00887868505478]
Moist Heat or Steam Sterilization
[00887868505478]
Moist Heat or Steam Sterilization
[00887868505478]
Moist Heat or Steam Sterilization
[00887868505478]
Moist Heat or Steam Sterilization
[00887868505478]
Moist Heat or Steam Sterilization
[00887868505478]
Moist Heat or Steam Sterilization
[00887868505478]
Moist Heat or Steam Sterilization
[00887868505478]
Moist Heat or Steam Sterilization
[00887868505478]
Moist Heat or Steam Sterilization
[00887868505478]
Moist Heat or Steam Sterilization
[00887868505478]
Moist Heat or Steam Sterilization
[00887868505478]
Moist Heat or Steam Sterilization
[00887868505478]
Moist Heat or Steam Sterilization
[00887868505478]
Moist Heat or Steam Sterilization
[00887868505478]
Moist Heat or Steam Sterilization
[00887868505478]
Moist Heat or Steam Sterilization
[00887868505478]
Moist Heat or Steam Sterilization
[00887868505478]
Moist Heat or Steam Sterilization
[00887868505478]
Moist Heat or Steam Sterilization
[00887868505478]
Moist Heat or Steam Sterilization
[00887868505478]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-03-28 |
| Device Publish Date | 2022-03-19 |
Devices Manufactured by Biomet Orthopedics, LLC
| 00887868578250 - Comprehensive® | 2024-11-13 |
| 08428898885684 - BIPASS DISPOSABLE PUSHER | 2024-09-11 |
| 08428898885691 - BIPASS DISPOSABLE PUSHER | 2024-09-11 |
| 00880304338548 - AGC ANTERIOR FILE | 2024-09-11 |
| 00880304339224 - PARALLEL PULLER | 2024-09-11 |
| 00880304342187 - AGC MODULAR TIBIAL II | 2024-09-11 |
| 00880304365247 - BIO-MODULAR | 2024-09-11 |
| 00880304368637 - BOHN MODULAR FEMORAL STEM EXTRACTOR | 2024-09-11 |
Trademark Results [Versa-Dial]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VERSA-DIAL 78077176 3382658 Live/Registered |
BIOMET MANUFACTURING, LLC 2001-08-02 |
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