Remedy Spacer RRTINMD

GUDID 00855195006982

REMEDY® RADEL® Tibial Insert Wedge Trial Medium

OSTEOREMEDIES, LLC

Knee tibia prosthesis trial, reusable Knee tibia prosthesis trial, reusable Knee tibia prosthesis trial, reusable Knee tibia prosthesis trial, reusable Knee tibia prosthesis trial, reusable Knee tibia prosthesis trial, reusable Knee tibia prosthesis trial, reusable Knee tibia prosthesis trial, reusable Knee tibia prosthesis trial, reusable Knee tibia prosthesis trial, reusable Knee tibia prosthesis trial, reusable Knee tibia prosthesis trial, reusable Knee tibia prosthesis trial, reusable Knee tibia prosthesis trial, reusable Knee tibia prosthesis trial, reusable

• Primary Device ID: 00855195006982
• NIH Device Record Key: 102571b0-cad2-4c14-9552-5ecb92479afa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Remedy Spacer
• Version Model Number: RRTINMD
• Catalog Number: RRTINMD
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00855195006982 [Primary]

FDA Product Code

• HWT: Template

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00855195006982]

Moist Heat or Steam Sterilization

[00855195006982]

Moist Heat or Steam Sterilization

[00855195006982]

Moist Heat or Steam Sterilization

[00855195006982]

Moist Heat or Steam Sterilization

[00855195006982]

Moist Heat or Steam Sterilization

[00855195006982]

Moist Heat or Steam Sterilization

[00855195006982]

Moist Heat or Steam Sterilization

[00855195006982]

Moist Heat or Steam Sterilization

[00855195006982]

Moist Heat or Steam Sterilization

[00855195006982]

Moist Heat or Steam Sterilization

[00855195006982]

Moist Heat or Steam Sterilization

[00855195006982]

Moist Heat or Steam Sterilization

[00855195006982]

Moist Heat or Steam Sterilization

[00855195006982]

Moist Heat or Steam Sterilization

[00855195006982]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-13
• Device Publish Date: 2022-12-05

On-Brand Devices [Remedy Spacer ]

• 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