Ambler Surgical

Basic Information

• Brand Name: Ambler Surgical
• Primary DI: 00190660156879
• Version / Model: Azar corneal scissors
• Catalog Number: 5847E
• 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: 3
• Public Version Date: 2023-10-18
• Public Version Status: Update
• Public Device Record Key: 0c987265-e30c-4642-a199-8eec071a4780

Device Description

Azar corneal scissors, 4 1/2'', universal medium model, curved 16.0mm blades, blunt tips, calibration markings at 1 to 6.0mm, 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
HNF	SCISSORS, OPHTHALMIC	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13486	Corneal scissors, reusable	A hand-held, manual, ophthalmic surgical instrument intended to be used to cut corneal tissue (e.g., during cataract extraction surgery, corneal transplant surgery). It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is typically made of metal and is available in various designs and sizes; some designs may additionally be used for cutting sutures and drapes. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00190660156879	GS1

Customer Contacts

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