Ambler Surgical

Basic Information

• Brand Name: Ambler Surgical
• Primary DI: 00190660140977
• Version / Model: Ribbon retractor
• Catalog Number: 72-830
• 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: 1
• Public Version Date: 2021-01-12
• Public Version Status: New
• Public Device Record Key: 51dfc33d-7fdd-47a7-8bdf-2141a364100c

Device Description

Ribbon retractor, 10'', malleable, 1 1/4'' wide blade, flat 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
GAD	RETRACTOR	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36293	Abdominal/intestinal spatula	A hand-held manual surgical instrument designed to manipulate the intestines and organs of the abdomen during a surgical intervention in the abdominal cavity. It typically consists of a large, flat, blunt blade (no sharp edges) at the distal end and a strong handle at the proximal end. It is usually made of high-grade stainless steel and is available with a variety of blade designs (e.g., curved and flat or straight and flat with a rounded end, or right-angled); some blade types may have a serrated surface to help retain the slippery abdominal tissues. The handle is typically designed to provide a non-slip grip. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00190660140977	GS1

Customer Contacts

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