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Remedy Spacer

FDA UDI

Class I (US FDA UDI)

by Osteoremedies, Llc

Identity

Trade Name
Remedy Spacer FDA UDI
Generic Name
Humeral stem extension prosthesis trial FDA UDI
Device Name
REMEDY® RADEL® Humeral Stem Trial Medium FDA UDI
Model / Reference
RRTSSTMD FDA UDI
Description
REMEDY® RADEL® Humeral Stem Trial Medium FDA UDI

Identifiers

Catalog Number
RRTSSTMD FDA UDI
Primary DI / UDI-DI
00850011453049 FDA UDI
FDA Product Code
HWT FDA UDI
GMDN Term
Humeral stem extension prosthesis trial FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Humeral stem extension prosthesis trial

Remedy Spacer by Osteoremedies, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Humeral stem extension prosthesis trial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Osteoremedies, Llc

Sources (1)

  • FDA UDI 333417df-561a-49a1-b116-3a2fca60df55 34 fields · synced Jun 1, 2026