Primary Device ID | 00855195006760 |
NIH Device Record Key | cb6e5258-e772-42ae-a6f6-ae69fd9db00c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Remedy Spacer |
Version Model Number | RTSKTMD |
Catalog Number | RTSKTMD |
Company DUNS | 079596704 |
Company Name | OSTEOREMEDIES, 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 | false |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00855195006760 [Primary] |
HWT | Template |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00855195006760]
Moist Heat or Steam Sterilization
[00855195006760]
Moist Heat or Steam Sterilization
[00855195006760]
Moist Heat or Steam Sterilization
[00855195006760]
Moist Heat or Steam Sterilization
[00855195006760]
Moist Heat or Steam Sterilization
[00855195006760]
Moist Heat or Steam Sterilization
[00855195006760]
Moist Heat or Steam Sterilization
[00855195006760]
Moist Heat or Steam Sterilization
[00855195006760]
Moist Heat or Steam Sterilization
[00855195006760]
Moist Heat or Steam Sterilization
[00855195006760]
Moist Heat or Steam Sterilization
[00855195006760]
Moist Heat or Steam Sterilization
[00855195006760]
Moist Heat or Steam Sterilization
[00855195006760]
Moist Heat or Steam Sterilization
[00855195006760]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-12-13 |
Device Publish Date | 2022-12-05 |
00855195006517 | Remedy Acetabular Cup |
00855195006500 | Remedy Femoral Component 84mm |
00855195006494 | Unite AB Bone Cement |
00855195006487 | Remedy Modular Humeral Stem Large |
00855195006470 | Remedy Modular Humeral Stem Medium |
00855195006463 | Remedy Modular Humeral Stem Small |
00855195006456 | Remedy Modular Humeral Head 50mm |
00855195006449 | Remedy Modular Humeral Head 45mm |
00855195006432 | Remedy Modular Humeral Head 40mm |
00855195006425 | Remedy Tibial Insert 80mm |
00855195006418 | Remedy Tibial Insert 70mm |
00855195006401 | Remedy Tibial Insert 60mm |
00855195006395 | Remedy Femoral Component 74mm |
00855195006388 | Remedy Femoral Component 64mm |
00855195006371 | Remedy Femoral Component 54mm |
00855195006364 | Remedy Tibial Component 80mm |
00855195006357 | Remedy Tibial Component 70mm |
00855195006340 | Remedy Tibial Component 60mm |
00855195006333 | Remedy Modular Long Stem Large |
00855195006326 | Remedy Modular Long Stem Medium |
00855195006319 | Remedy Modular Long Stem Small |
00855195006302 | Remedy Modular Stem Large |
00855195006296 | Remedy Modular Stem Medium |
00855195006289 | Remedy Modular Stem Small |
00855195006272 | Remedy Modular Head 60mm |
00855195006265 | Remedy Modular Head 54mm |
00855195006258 | Remedy Modular Head 46mm |
00855195006234 | Remedy Shoulder Humeral Stem Large |
00855195006227 | Remedy Shoulder Humeral Stem Medium |
00855195006210 | Remedy Shoulder Humeral Stem Small |
00855195006203 | Remedy Shoulder Humeral Head 50mm |
00855195006197 | Remedy Shoulder Humeral Head 45mm |
00855195006180 | Remedy Shoulder Humeral Head 40mm |
00855195006173 | Remedy Tibial Insert Wedge 80mm |
00855195006166 | Remedy Tibial Insert Wedge 70mm |
00855195006159 | Remedy Tibial Insert Wedge 60mm |
00855195006142 | Remedy Femoral Component 74mm |
00855195006135 | Remedy Femoral Component 64mm |
00855195006128 | Remedy Femoral Component 54mm |
00855195006111 | Remedy Tibial Component 80mm |
00855195006104 | Remedy Tibial Component 70mm |
00855195006098 | Remedy Tibial Component 60mm |
00855195006081 | Remedy Modular Long Stem Large |
00855195006074 | Remedy Modular Long Stem Medium |
00855195006067 | Remedy Modular Long Stem Small |
00855195006050 | Remedy Modular Stem Large |
00855195006043 | Remedy Modular Stem Medium |
00855195006036 | Remedy Modular Stem Small |
00855195006029 | Remedy Modular Head 60mm |
00855195006012 | Remedy Modular Head 54mm |