Ambler Surgical

Basic Information

• Brand Name: Ambler Surgical
• Primary DI: 00190660015312
• Version / Model: Glassman intestinal and liver holding clamp
• Catalog Number: 18-332
• Company Name: AMBLER SURGICAL CORP.
• Labeler DUNS: 015272206
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-04
• Public Version: 2
• Public Version Date: 2021-07-22
• Public Version Status: Update
• Public Device Record Key: e9075a77-62fd-4da7-9e4f-82bb89e611f1

Device Description

Glassman intestinal and liver holding clamp, 9 1/2'', fully curved, non-crushing serrated jaws, ring handle

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
GDJ	CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64147	Surgical gastrointestinal clamp	A manual, clip-like, surgical device designed specifically to clamp tissues of the gastrointestinal tract (e.g., colon) during open surgery; it does not have handles (i.e., not forceps-like) and is not intended for general manipulation/dissection of tissues. It may be referred to as a Demartel-Wolfson Clamp and is designed with blades hinged at one end and with a locking bar at the other. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00190660015312	GS1

Customer Contacts

• Phone: [phone] ext. 0
• Email: [email protected]