Primary Device ID | 00887868050190 |
NIH Device Record Key | 9689ed1a-86f7-4799-9f5d-14900eeb3e87 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | POLYAX®CALIBRATED GUIDE PIN |
Version Model Number | 8291-32-009 |
Catalog Number | 829132009 |
Company DUNS | 129278169 |
Company Name | Biomet Orthopedics, LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 |
Phone | +1(800)348-9500 |
customerservice@zimmerbiomet.com |
Device Size Text, specify | 0 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00887868050190 [Primary] |
FZX | Guide, surgical, instrument |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2024-02-19 |
Device Publish Date | 2020-05-23 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
POLYAX 78464561 3181622 Live/Registered |
BIOMET C.V. 2004-08-09 |