STERNALOCK® BLU SYSTEM SP-3215
GUDID 00888233018074
BIOMET MICROFIXATION, INC
Craniofacial fixation plate, non-bioabsorbable| Primary Device ID | 00888233018074 |
| NIH Device Record Key | 2032f422-78b0-4448-a3e9-92ba6a87325c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | STERNALOCK® BLU SYSTEM |
| Version Model Number | SP-3215 |
| Catalog Number | SP-3215 |
| 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 | 00888233018074 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K121302
FDA Product Code
| HRS | Plate, fixation, bone |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00888233018074]
Moist Heat or Steam Sterilization
[00888233018074]
Moist Heat or Steam Sterilization
[00888233018074]
Moist Heat or Steam Sterilization
[00888233018074]
Moist Heat or Steam Sterilization
[00888233018074]
Moist Heat or Steam Sterilization
[00888233018074]
Moist Heat or Steam Sterilization
[00888233018074]
Moist Heat or Steam Sterilization
[00888233018074]
Moist Heat or Steam Sterilization
[00888233018074]
Moist Heat or Steam Sterilization
[00888233018074]
Moist Heat or Steam Sterilization
[00888233018074]
Moist Heat or Steam Sterilization
[00888233018074]
Moist Heat or Steam Sterilization
[00888233018074]
Moist Heat or Steam Sterilization
[00888233018074]
Moist Heat or Steam Sterilization
[00888233018074]
Moist Heat or Steam Sterilization
[00888233018074]
Moist Heat or Steam Sterilization
[00888233018074]
Moist Heat or Steam Sterilization
[00888233018074]
Moist Heat or Steam Sterilization
[00888233018074]
Moist Heat or Steam Sterilization
[00888233018074]
Moist Heat or Steam Sterilization
[00888233018074]
Moist Heat or Steam Sterilization
[00888233018074]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2021-02-05 |
| Device Publish Date | 2020-06-17 |
On-Brand Devices [STERNALOCK® BLU SYSTEM]
Trademark Results [STERNALOCK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STERNALOCK 78582263 3076302 Live/Registered |
ZIMMER BIOMET CMF AND THORACIC, LLC 2005-03-08 |
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