TEMPFIX®ANKLE TRANSFIXING PIN - LEFT 818109000
GUDID 00887868047725
Biomet Orthopedics, LLC
External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use| Primary Device ID | 00887868047725 |
| NIH Device Record Key | c1cc1a9f-60f5-4045-8e4b-db8e0b86589d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TEMPFIX®ANKLE TRANSFIXING PIN - LEFT |
| Version Model Number | 8181-09-000 |
| Catalog Number | 818109000 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00887868047725 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K021933
FDA Product Code
| HWC | Screw, fixation, bone |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00887868047725]
Moist Heat or Steam Sterilization
[00887868047725]
Moist Heat or Steam Sterilization
[00887868047725]
Moist Heat or Steam Sterilization
[00887868047725]
Moist Heat or Steam Sterilization
[00887868047725]
Moist Heat or Steam Sterilization
[00887868047725]
Moist Heat or Steam Sterilization
[00887868047725]
Moist Heat or Steam Sterilization
[00887868047725]
Moist Heat or Steam Sterilization
[00887868047725]
Moist Heat or Steam Sterilization
[00887868047725]
Moist Heat or Steam Sterilization
[00887868047725]
Moist Heat or Steam Sterilization
[00887868047725]
Moist Heat or Steam Sterilization
[00887868047725]
Moist Heat or Steam Sterilization
[00887868047725]
Moist Heat or Steam Sterilization
[00887868047725]
Moist Heat or Steam Sterilization
[00887868047725]
Moist Heat or Steam Sterilization
[00887868047725]
Moist Heat or Steam Sterilization
[00887868047725]
Moist Heat or Steam Sterilization
[00887868047725]
Moist Heat or Steam Sterilization
[00887868047725]
Moist Heat or Steam Sterilization
[00887868047725]
Moist Heat or Steam Sterilization
[00887868047725]
Moist Heat or Steam Sterilization
[00887868047725]
Moist Heat or Steam Sterilization
[00887868047725]
Moist Heat or Steam Sterilization
[00887868047725]
Moist Heat or Steam Sterilization
[00887868047725]
Moist Heat or Steam Sterilization
[00887868047725]
Moist Heat or Steam Sterilization
[00887868047725]
Moist Heat or Steam Sterilization
[00887868047725]
Moist Heat or Steam Sterilization
[00887868047725]
Moist Heat or Steam Sterilization
[00887868047725]
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 |
Devices Manufactured by Biomet Orthopedics, LLC
| 00887868004087 - PRIMARY TREPHINE | 2024-04-03 |
| 00887868004094 - BUSHING | 2024-04-03 |
| 00887868004100 - SECONDARY TREPHINE | 2024-04-03 |
| 00887868048272 - TREPHINE | 2024-04-03 |
| 00887868048289 - TREPHINE | 2024-04-03 |
| 00887868048296 - TREPHINE | 2024-04-03 |
| 00887868048302 - TREPHINE | 2024-04-03 |
| 00880304658387 - Compress® | 2024-03-11 |
Trademark Results [TEMPFIX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TEMPFIX 78624746 3085280 Live/Registered |
BIOMET C.V. 2005-05-06 |
 TEMPFIX 78080215 not registered Dead/Abandoned |
DePuy, Inc. 2001-08-20 |
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