MSI Precision Specialty Instruments

Basic Information

• Brand Name: MSI Precision Specialty Instruments
• Primary DI: 00194613103484
• Version / Model: 332-342-21
• Company Name: Med Saver, Inc.
• Labeler DUNS: 556623486
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-21
• Public Version: 2
• Public Version Date: 2025-07-30
• Public Version Status: Update
• Public Device Record Key: 2d298533-f5a9-4cc8-9b91-573dc51049f2

Device Description

Gomco Circumcision Instrument, 21mm

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: No

Sterilization

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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FHA	CLAMP, PENILE	Gastroenterology, Urology	876.5160	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38523	Surgical penis clamp, single-use	A sterile, 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 single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00194613103484	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]