Hayden Medical

FDA UDI

Class I (US FDA UDI)

by Hayden Medical Inc

Identity

Trade Name: Hayden Medical FDA UDI
Generic Name: Surgical penis clamp, single-use FDA UDI
Device Name: Gomco Circumcision Clamp, newborn, 1.3cm FDA UDI
Model / Reference: 382-113 FDA UDI
Description: Gomco Circumcision Clamp, newborn, 1.3cm FDA UDI

Identifiers

Catalog Number: 382-113 FDA UDI
Primary DI / UDI-DI: 00840319750711 FDA UDI
FDA Product Code: MDM FDA UDI
GMDN Term: Surgical penis clamp, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

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

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical penis clamp, single-use

Hayden Medical by Hayden Medical Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical penis clamp, single-use.

PENIS CLAMP — DR.FRIGZ INTERNATIONAL(PVT)LTD, · Class I
Medline Industries, Inc. — MEDLINE INDUSTRIES, INC. · Class II
Centurion — Centurion Medical Products · Class II
MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
ShangRing — Wuhu Snnda Medical Treatment Appliance Technology · Class II
Centurion — Centurion Medical Products · Class II
MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
Centurion — Centurion Medical Products · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Hayden Medical Inc

Sources (1)

FDA UDI 50a8c339-a1ea-4d1b-b23c-39eb5a2fd982 35 fields · synced May 30, 2026