Ambler Surgical

Basic Information

• Brand Name: Ambler Surgical
• Primary DI: 00190660136611
• Version / Model: Henly retractor
• Catalog Number: 71-895
• Company Name: AMBLER SURGICAL CORP.
• Labeler DUNS: 015272206
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-07
• Public Version: 2
• Public Version Date: 2021-05-10
• Public Version Status: Update
• Public Device Record Key: 3fd5a56d-3120-455f-bd0f-90a30d0031d1

Device Description

Henly retractor, 6 1/2'', interchangeable blades, complete set includes 3 pairs of side blades 1'' x 7/8'' wide, 2'' x 7/8'' wide and 3'' x 7/8'' wide, with 4 blunt prongs, also 3 center blades 3/4'' x 5/8'' wide, 1'' x 5/8'' wide and 1 1/4'' x 5/8'' wide, ring handle with ratchet catch (71-890, 71-891, 71-892, 71-850, 71-851, 71-852 and 71-855)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
FFO	RETRACTOR, SELF-RETAINING	Gastroenterology, Urology	876.4730	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46774	Surgical retractor/retraction system blade, reusable	A distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge to separate the margins of a wound/incision during a surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is a metal device, sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle, because it is available in a variety of lengths and sizes. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00190660136611	GS1

Customer Contacts

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