Ambler Surgical

Basic Information

• Brand Name: Ambler Surgical
• Primary DI: 00190660216412
• Version / Model: Wullstein ear scissors
• Catalog Number: 80-630
• 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: 32d89cfa-9f65-4f9d-a9ed-e6b7c887a3af

Device Description

Wullstein ear scissors, 4 1/2'', working length 65.0mm, fine, curved right 5.0mm blades, sharp tips, 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
JZB	SCISSORS, EAR	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33414	Ear scissors, reusable	A long, thin, hand-held manual surgical instrument designed to cut tissue during ear surgery; it is not intended for insertion through an endoscope. Sometimes referred to as alligator scissors, it typically has a slender body (to allow for restricted access) and small shearing blades which are hinged at the distal (working) end. It is made of metal and available in various sizes/lengths; the blades may have carbide inserts along the cutting edges. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00190660216412	GS1

Customer Contacts

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