Ambler Surgical

Basic Information

• Brand Name: Ambler Surgical
• Primary DI: 00190660016142
• Version / Model: 17-643
• Catalog Number: 17-643
• Company Name: AMBLER SURGICAL CORP.
• Labeler DUNS: 015272206
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-29
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 6b7d6de8-78df-430a-9f5d-ad9cceece95f

Device Description

Kay aortic anastomosis clamp, 8", angled shanks, curved, 4.5cm wide x 3.2cm deep atraumatic jaws, ring handle, titanium

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: No
• 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
DXC	CLAMP, VASCULAR	Cardiovascular	870.4450	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43142	Vascular anastomosis clamp	A surgical instrument used to perform a vascular anastamosis (surgical communication between two or more veins or arteries) by compressing the vessels to ensure haemostasis (arrest or prevention of bleeding) before the procedure. It is typically self-retaining and has a scissors-like design with ring handles and blades of various designs (e.g., curved, angled, or semicircular) at the working end, or it may be designed with levers that are locked into position at the site of intervention. It is typically made of high-grade stainless steel and may utilize carbide inserts; it is available in various sizes for different applications. This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00190660016142	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K092544	000