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Wrist Drop w/ U-Cuff Hand Splint

FDA UDI

Class I (US FDA UDI)

by Primo Inc

Identity

Trade Name
Wrist Drop w/ U-Cuff Hand Splint FDA UDI
Generic Name
Hand/finger splint, single-use FDA UDI
Device Name
Wrist Drop w/ U-Cuff Hand Splint - Small (Left) FDA UDI
Model / Reference
WDS01LS FDA UDI
Description
Wrist Drop w/ U-Cuff Hand Splint - Small (Left) FDA UDI

Identifiers

Catalog Number
WDS01LS FDA UDI
Primary DI / UDI-DI
00810006682489 FDA UDI
FDA Product Code
ILH FDA UDI
GMDN Term
Hand/finger splint, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3475 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Hand/finger splint, single-use

Wrist Drop w/ U-Cuff Hand Splint by Primo Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hand/finger splint, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Primo Inc

Sources (1)

  • FDA UDI 7ff152a0-9fae-446d-8e64-fe6e294e575c 34 fields · synced Jun 1, 2026