| Primary Device ID | 00841036128609 |
| NIH Device Record Key | 1efa75a6-44f4-4f91-a11e-4ec4d0ef193f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TraumaOne SYSTEM |
| Version Model Number | 46-0013 |
| Catalog Number | 46-0013 |
| Company DUNS | 046189866 |
| Company Name | BIOMET MICROFIXATION, INC |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841036128609 [Primary] |
| KTE | TROCAR, ENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00841036128609]
Moist Heat or Steam Sterilization
[00841036128609]
Moist Heat or Steam Sterilization
[00841036128609]
Moist Heat or Steam Sterilization
[00841036128609]
Moist Heat or Steam Sterilization
[00841036128609]
Moist Heat or Steam Sterilization
[00841036128609]
Moist Heat or Steam Sterilization
[00841036128609]
Moist Heat or Steam Sterilization
[00841036128609]
Moist Heat or Steam Sterilization
[00841036128609]
Moist Heat or Steam Sterilization
[00841036128609]
Moist Heat or Steam Sterilization
[00841036128609]
Moist Heat or Steam Sterilization
[00841036128609]
Moist Heat or Steam Sterilization
[00841036128609]
Moist Heat or Steam Sterilization
[00841036128609]
Moist Heat or Steam Sterilization
[00841036128609]
Moist Heat or Steam Sterilization
[00841036128609]
Moist Heat or Steam Sterilization
[00841036128609]
Moist Heat or Steam Sterilization
[00841036128609]
Moist Heat or Steam Sterilization
[00841036128609]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-08 |
| Device Publish Date | 2018-09-07 |