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Elbow

FDA UDI

Class I (US FDA UDI)

by Hugh Steeper Limited

Identity

Trade Name
Elbow FDA UDI
Generic Name
Body-powered elbow prosthesis, locking FDA UDI
Model / Reference
Automatic Elbow, Adult, Flesh Pink FDA UDI

Identifiers

Catalog Number
5055348247803 FDA UDI
Primary DI / UDI-DI
05055348247803 FDA UDI
FDA Product Code
IRD FDA UDI
GMDN Term
Body-powered elbow prosthesis, locking FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3420 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

No

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Body-powered elbow prosthesis, locking

Elbow by Hugh Steeper Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Body-powered elbow prosthesis, locking.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI df450321-dcf1-4137-940e-3c46dda60c84 33 fields · synced May 30, 2026