GOMCO

Basic Information

• Brand Name: GOMCO
• Primary DI: 00026072002292
• Version / Model: 02-00-0500
• Catalog Number: 02-00-0500
• Company Name: ALLIED HEALTHCARE PRODUCTS, INC.
• Labeler DUNS: 099674145
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-16
• Public Version: 3
• Public Version Date: 2020-05-08
• Public Version Status: Update
• Public Device Record Key: 481e50d8-a126-42d7-98e7-c76c008a2c26

Device Description

500S CIRC. CLAMP EX SMALL 1.1

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: Yes

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HFX	Clamp, Circumcision	Obstetrics/Gynecology	884.4530	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35803	Surgical penis clamp, reusable	A hand-held manual surgical instrument designed to grasp the penis for manipulation during surgery (e.g., circumcision). It is typically a clip-like device e.g., with self-retaining levers. The penis is placed into this clamp that closes around or on the organ. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00026072002292	GS1