Ambler Surgical

Basic Information

• Brand Name: Ambler Surgical
• Primary DI: 00190660179199
• Version / Model: Hirschman rectal anoscope speculum
• Catalog Number: 86-507
• 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: 2023-11-17
• Public Version Status: Update
• Public Device Record Key: d33748eb-e9c7-4385-aab5-5cc77cc4a901

Device Description

Hirschman rectal anoscope speculum, medium, 2 5/8'' long x 11/16'' diameter

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
FXE	SPECULUM, NON-ILLUMINATED	General, Plastic Surgery	878.1800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35255	Optical proctoscope, reusable	An endoscope with a rigid inserted portion intended for the visual examination and treatment of the rectum and anus. It is inserted into the body through the anus during proctoscopy. The anatomical images are illuminated by a built-in or external light source and can be viewed by the user through direct or magnified viewing, or a fibreoptic bundle. This device is longer than an anoscope to provide a deeper view. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00190660179199	GS1

Customer Contacts

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