Primary Device ID | 00815482020985 |
NIH Device Record Key | 66299722-c417-44b1-ae61-c61043f16fa3 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | GTFx™ Greater Tuberosity Fracture Plate System |
Version Model Number | SO03-3101 |
Catalog Number | SO03-3101 |
Company DUNS | 053545528 |
Company Name | Shoulder Options, Inc. |
Device Count | 1 |
DM Exempt | true |
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 | true |
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 |
Phone | 704-512-0000 |
burgan@shoulderoptions.com | |
Phone | 704-512-0000 |
burgan@shoulderoptions.com | |
Phone | 704-512-0000 |
burgan@shoulderoptions.com | |
Phone | 704-512-0000 |
burgan@shoulderoptions.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00815482020985 [Primary] |
HWC | Screw, Fixation, Bone |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00815482020985]
Moist Heat or Steam Sterilization
[00815482020985]
Moist Heat or Steam Sterilization
[00815482020985]
Moist Heat or Steam Sterilization
[00815482020985]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2015-11-02 |
00815482021012 | GTF Guide Handle |
00815482021005 | GTF Guide Plate, Right |
00815482020992 | GTF Guide Plate, Left |
00815482020985 | GTF Plate, Right |
00815482020978 | GTF Plate, Left |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
GTFX 88588463 not registered Live/Pending |
Wisteria Sky Pty Ltd ATF Wisteria Sky Family Trust 2019-08-22 |