Greenwald Surgical Company, Inc.

FDA UDI

Class I (US FDA UDI)

by Grace Manufacturing Inc

Identity

Trade Name: Greenwald Surgical Company, Inc. FDA UDI
Generic Name: Incontinence penis clamp, reusable FDA UDI
Device Name: Cunningham incontinence clamp, Regular FDA UDI
Model / Reference: C8021-00 FDA UDI
Description: Cunningham incontinence clamp, Regular FDA UDI

Identifiers

Primary DI / UDI-DI: 10801334000745 FDA UDI
FDA Product Code: FHA FDA UDI
GMDN Term: Incontinence penis clamp, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 876.5160 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Liquid Chemical FDA UDI

Category: Incontinence penis clamp, reusable

Greenwald Surgical Company, Inc. by Grace Manufacturing Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Grace Manufacturing Inc

Sources (1)

FDA UDI fe54f8b1-bbd1-421c-8cb1-e7d7e34fa583 34 fields · synced May 30, 2026