GEM BIOVER Microvascular Clamp

Basic Information

• Brand Name: GEM BIOVER Microvascular Clamp
• Primary DI: 00844735006315
• Version / Model: TKSV2
• Catalog Number: TKSV2
• Company Name: SYNOVIS MICRO COMPANIES ALLIANCE, INC
• Labeler DUNS: 031284586
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-04-19
• Public Version: 2
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 12708732-2628-4901-9021-de16bb1ac297

Device Description

Microvascular clamps are used for end-to-end anastomotic procedures for arteries and veins

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DXC	CLAMP, VASCULAR	Cardiovascular	870.4450	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62480	Surgical bulldog clamp, single-use	A manual surgical instrument designed to grasp, join, compress or support an organ, vessel or soft-tissue. It has a flat, pincer-like design with self-retaining jaws that open upon squeezing of the handles and close upon release; it is typically made of plastic. It is commonly used for vascular clamping and is not dedicated to a specific type of non-vascular surgery. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10844735006312	GS1	CASE	10	In Commercial Distribution
Primary	00844735006315	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]