POLYAX®TIBIAL PLATE - LEFT 814133005
GUDID 00887868037047
Biomet Orthopedics, LLC
Orthopaedic fixation plate, non-bioabsorbable, sterile| Primary Device ID | 00887868037047 |
| NIH Device Record Key | c91015c2-2249-4ca1-8fe9-8746f6e605f0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | POLYAX®TIBIAL PLATE - LEFT |
| Version Model Number | 8141-33-005 |
| Catalog Number | 814133005 |
| 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 | true |
| 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 |
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Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00887868037047 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
FDA Product Code
| KTT | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
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 [POLYAX®TIBIAL PLATE - LEFT]
| 00887868015731 | 1486-07-014 |
| 00887868015724 | 1486-07-011 |
| 00887868015717 | 1486-07-008 |
| 00887868015700 | 1486-07-005 |
| 00887868015694 | 1486-07-002 |
| 00887868037078 | 8141-33-014 |
| 00887868037061 | 8141-33-011 |
| 00887868037054 | 8141-33-008 |
| 00887868037047 | 8141-33-005 |
| 00887868037030 | 8141-33-002 |
Trademark Results [POLYAX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 POLYAX 78464561 3181622 Live/Registered |
BIOMET C.V. 2004-08-09 |
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