T-PLATE 935910004
GUDID 00887868124631
Biomet Orthopedics, LLC
Orthopaedic fixation plate, non-bioabsorbable, sterile| Primary Device ID | 00887868124631 |
| NIH Device Record Key | 06954d37-271a-4c59-9a48-313c85956bf5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | T-PLATE |
| Version Model Number | 935910004 |
| Catalog Number | 935910004 |
| 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 | 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 Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00887868124631 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K111663
FDA Product Code
| HSB | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00887868124631]
Moist Heat or Steam Sterilization
[00887868124631]
Moist Heat or Steam Sterilization
[00887868124631]
Moist Heat or Steam Sterilization
[00887868124631]
Moist Heat or Steam Sterilization
[00887868124631]
Moist Heat or Steam Sterilization
[00887868124631]
Moist Heat or Steam Sterilization
[00887868124631]
Moist Heat or Steam Sterilization
[00887868124631]
Moist Heat or Steam Sterilization
[00887868124631]
Moist Heat or Steam Sterilization
[00887868124631]
Moist Heat or Steam Sterilization
[00887868124631]
Moist Heat or Steam Sterilization
[00887868124631]
Moist Heat or Steam Sterilization
[00887868124631]
Moist Heat or Steam Sterilization
[00887868124631]
Moist Heat or Steam Sterilization
[00887868124631]
Moist Heat or Steam Sterilization
[00887868124631]
Moist Heat or Steam Sterilization
[00887868124631]
Moist Heat or Steam Sterilization
[00887868124631]
Moist Heat or Steam Sterilization
[00887868124631]
Moist Heat or Steam Sterilization
[00887868124631]
Moist Heat or Steam Sterilization
[00887868124631]
Moist Heat or Steam Sterilization
[00887868124631]
Moist Heat or Steam Sterilization
[00887868124631]
Moist Heat or Steam Sterilization
[00887868124631]
Moist Heat or Steam Sterilization
[00887868124631]
Moist Heat or Steam Sterilization
[00887868124631]
Moist Heat or Steam Sterilization
[00887868124631]
Moist Heat or Steam Sterilization
[00887868124631]
Moist Heat or Steam Sterilization
[00887868124631]
Moist Heat or Steam Sterilization
[00887868124631]
Moist Heat or Steam Sterilization
[00887868124631]
Moist Heat or Steam Sterilization
[00887868124631]
Moist Heat or Steam Sterilization
[00887868124631]
Moist Heat or Steam Sterilization
[00887868124631]
Moist Heat or Steam Sterilization
[00887868124631]
Moist Heat or Steam Sterilization
[00887868124631]
Moist Heat or Steam Sterilization
[00887868124631]
Moist Heat or Steam Sterilization
[00887868124631]
Moist Heat or Steam Sterilization
[00887868124631]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-10-24 |
On-Brand Devices [T-PLATE]
| 00887868124679 | 935910008 |
| 00887868124662 | 935910007 |
| 00887868124655 | 935910006 |
| 00887868124648 | 935910005 |
| 00887868124631 | 935910004 |
| 00887868124624 | 935910003 |
Trademark Results [T-PLATE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 T-PLATE 75506830 2470047 Dead/Cancelled |
Ano-Coil Corporation 1998-06-22 |
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