BIO-MODULAR® CHOICE INSTRUMENTS 406668
GUDID 00880304447820
Biomet Orthopedics, LLC
Orthopaedic implant inserter/extractor, reusable| Primary Device ID | 00880304447820 |
| NIH Device Record Key | d114b78b-23f3-404b-a812-651ec78b5d26 |
| 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 | 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 | 00880304447820 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K132239
FDA Product Code
| HWB | EXTRACTOR |
| KWS | PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00880304447820]
Moist Heat or Steam Sterilization
[00880304447820]
Moist Heat or Steam Sterilization
[00880304447820]
Moist Heat or Steam Sterilization
[00880304447820]
Moist Heat or Steam Sterilization
[00880304447820]
Moist Heat or Steam Sterilization
[00880304447820]
Moist Heat or Steam Sterilization
[00880304447820]
Moist Heat or Steam Sterilization
[00880304447820]
Moist Heat or Steam Sterilization
[00880304447820]
Moist Heat or Steam Sterilization
[00880304447820]
Moist Heat or Steam Sterilization
[00880304447820]
Moist Heat or Steam Sterilization
[00880304447820]
Moist Heat or Steam Sterilization
[00880304447820]
Moist Heat or Steam Sterilization
[00880304447820]
Moist Heat or Steam Sterilization
[00880304447820]
Moist Heat or Steam Sterilization
[00880304447820]
Moist Heat or Steam Sterilization
[00880304447820]
Moist Heat or Steam Sterilization
[00880304447820]
Moist Heat or Steam Sterilization
[00880304447820]
Moist Heat or Steam Sterilization
[00880304447820]
Moist Heat or Steam Sterilization
[00880304447820]
Moist Heat or Steam Sterilization
[00880304447820]
Moist Heat or Steam Sterilization
[00880304447820]
Moist Heat or Steam Sterilization
[00880304447820]
Moist Heat or Steam Sterilization
[00880304447820]
Moist Heat or Steam Sterilization
[00880304447820]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-04-23 |
| Device Publish Date | 2017-07-28 |
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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.