Bio-Modular® Choice Instruments 406668
GUDID 00887868513084
Biomet Orthopedics, LLC
Orthopaedic implant inserter/extractor, reusable| Primary Device ID | 00887868513084 |
| NIH Device Record Key | 7ca79c00-f866-471e-9601-e5b96167864d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bio-Modular® Choice Instruments |
| Version Model Number | 406668 |
| Catalog Number | 406668 |
| 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 | 00887868513084 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K132239
FDA Product Code
| KWS | PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00887868513084]
Moist Heat or Steam Sterilization
[00887868513084]
Moist Heat or Steam Sterilization
[00887868513084]
Moist Heat or Steam Sterilization
[00887868513084]
Moist Heat or Steam Sterilization
[00887868513084]
Moist Heat or Steam Sterilization
[00887868513084]
Moist Heat or Steam Sterilization
[00887868513084]
Moist Heat or Steam Sterilization
[00887868513084]
Moist Heat or Steam Sterilization
[00887868513084]
Moist Heat or Steam Sterilization
[00887868513084]
Moist Heat or Steam Sterilization
[00887868513084]
Moist Heat or Steam Sterilization
[00887868513084]
Moist Heat or Steam Sterilization
[00887868513084]
Moist Heat or Steam Sterilization
[00887868513084]
Moist Heat or Steam Sterilization
[00887868513084]
Moist Heat or Steam Sterilization
[00887868513084]
Moist Heat or Steam Sterilization
[00887868513084]
Moist Heat or Steam Sterilization
[00887868513084]
Moist Heat or Steam Sterilization
[00887868513084]
Moist Heat or Steam Sterilization
[00887868513084]
Moist Heat or Steam Sterilization
[00887868513084]
Moist Heat or Steam Sterilization
[00887868513084]
Moist Heat or Steam Sterilization
[00887868513084]
Moist Heat or Steam Sterilization
[00887868513084]
Moist Heat or Steam Sterilization
[00887868513084]
Moist Heat or Steam Sterilization
[00887868513084]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-04-25 |
| Device Publish Date | 2022-04-16 |
On-Brand Devices [Bio-Modular® Choice Instruments]
| 00880304447820 | 406668 |
| 00887868505256 | 406802 |
| 00887868513084 | 406668 |
Trademark Results [Bio-Modular]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIO-MODULAR 73737260 1522520 Live/Registered |
BIOMET, INC. 1988-06-29 |
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