Ambler Surgical

Basic Information

• Brand Name: Ambler Surgical
• Primary DI: 00190660127220
• Version / Model: Bunnell tendon passer
• Catalog Number: 44-621
• 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: d8f1dbba-bcda-413e-a661-178ee36dd392

Device Description

Bunnell tendon passer, 9'', double-ended, malleable, 5.0mm 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
HWQ	PASSER	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35380	Tendon stripper	A hand-held manual surgical instrument designed to excise a length of ligament, tendon or fascia for use as a living graft. It typically consists of a handle and a semicircular shaped trough that terminates in a sharp cutting edge. It is typically made of high-grade stainless steel. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00190660127220	GS1

Customer Contacts

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