TraumaOne SP-3449
GUDID 00841036264062
BIOMET MICROFIXATION, INC
Craniofacial fixation plate, non-bioabsorbable| Primary Device ID | 00841036264062 |
| NIH Device Record Key | 953caa6d-a852-413c-9695-98d2eb8ca1f5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TraumaOne |
| Version Model Number | SP-3449 |
| Catalog Number | SP-3449 |
| Company DUNS | 046189866 |
| Company Name | BIOMET MICROFIXATION, INC |
| 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 | true |
| 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 | 00841036264062 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K113512
FDA Product Code
| HWC | Screw, fixation, bone |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00841036264062]
Moist Heat or Steam Sterilization
[00841036264062]
Moist Heat or Steam Sterilization
[00841036264062]
Moist Heat or Steam Sterilization
[00841036264062]
Moist Heat or Steam Sterilization
[00841036264062]
Moist Heat or Steam Sterilization
[00841036264062]
Moist Heat or Steam Sterilization
[00841036264062]
Moist Heat or Steam Sterilization
[00841036264062]
Moist Heat or Steam Sterilization
[00841036264062]
Moist Heat or Steam Sterilization
[00841036264062]
Moist Heat or Steam Sterilization
[00841036264062]
Moist Heat or Steam Sterilization
[00841036264062]
Moist Heat or Steam Sterilization
[00841036264062]
Moist Heat or Steam Sterilization
[00841036264062]
Moist Heat or Steam Sterilization
[00841036264062]
Moist Heat or Steam Sterilization
[00841036264062]
Moist Heat or Steam Sterilization
[00841036264062]
Moist Heat or Steam Sterilization
[00841036264062]
Moist Heat or Steam Sterilization
[00841036264062]
Moist Heat or Steam Sterilization
[00841036264062]
Moist Heat or Steam Sterilization
[00841036264062]
Moist Heat or Steam Sterilization
[00841036264062]
Moist Heat or Steam Sterilization
[00841036264062]
Moist Heat or Steam Sterilization
[00841036264062]
Moist Heat or Steam Sterilization
[00841036264062]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-06-25 |
| Device Publish Date | 2019-06-17 |
On-Brand Devices [TraumaOne]
| 00841036247577 | SP-3306 |
| 00841036247560 | SP-3305 |
| 00841036264062 | SP-3449 |
| 00841036264055 | SP-3448 |
| 00841036264048 | SP-3447 |
| 00841036264031 | SP-3446 |
| 00841036234485 | SP-3343 |
| 00841036234478 | SP-3342 |
| 00841036234461 | SP-3341 |
| 00841036231545 | SP-3350 |
| 00841036231538 | SP-3349 |
Trademark Results [TraumaOne]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRAUMAONE 75364977 2240390 Dead/Cancelled |
SHANDS JACKSONVILLE MEDICAL CENTER, INC. 1997-09-29 |
 TRAUMAONE 75222139 2204397 Dead/Cancelled |
DayStar Services, L.L.C. 1997-01-07 |
 TRAUMAONE 73628548 1468659 Dead/Cancelled |
UNIVERSITY MEDICAL CENTER, INC. 1986-11-04 |
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