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Revision Knee System

FDA UDI

Class I (US FDA UDI)

by Shalby Advanced Technologies, Inc.

Identity

Trade Name
Revision Knee System FDA UDI
Generic Name
Knee femur prosthesis trial, reusable FDA UDI
Device Name
RKS, Trial, Stem, Straight, 14mm x 110mm FDA UDI
Model / Reference
2971-0-1114 FDA UDI
Description
RKS, Trial, Stem, Straight, 14mm x 110mm FDA UDI

Identifiers

Catalog Number
2971-0-1114 FDA UDI
Primary DI / UDI-DI
00840286842556 FDA UDI
FDA Product Code
HWT FDA UDI
GMDN Term
Knee femur prosthesis trial, reusable 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: Knee femur prosthesis trial, reusableCPAP/BPAP oral mask

Revision Knee System by Shalby Advanced Technologies, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as CPAP/BPAP oral mask.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shalby Advanced Technologies, Inc.

Sources (1)

  • FDA UDI 59e1514b-40b4-4a87-8630-95a633854a1f 36 fields · synced Jun 1, 2026