Gelsoft™

Basic Information

• Brand Name: Gelsoft™
• Primary DI: 05037881110028
• Version / Model: 632010DB
• Catalog Number: 632010DB
• Company Name: VASCUTEK LTD
• Labeler DUNS: 229053087
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-19
• Public Version: 6
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: e46d3ece-601e-4bb7-992d-b1557519db56

Device Description

Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis DOUBLE BIFURCATE

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
DSY	PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER	Cardiovascular	870.3450	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35281	Synthetic vascular graft	An implantable artificial substitute for a blood vessel intended to replace or bypass the diseased or injured vessel. It is typically made of woven or knitted polyethylene terephthalate (Dacron) or polytetrafluoroethylene (PTFE) fabrics and is best suited for large (more than 10 mm) diameter, high-flow vessel replacement (e.g., aortic or aorto-iliac artery reconstruction) and also for haemodialysis access and extra-anatomic bypass grafting. The device is used in many vascular bypass procedures (e.g., aorto-iliac, femoral-popliteal, axillo-axillary artery) except those involving the coronary arteries.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05037881110028	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K162803	000
K990503	000

Device Sizes

Type	Value	Unit	Text
Length	45	Centimeter
Device Size Text, specify			Branch diameter 10/10 mm
Lumen/Inner Diameter	20	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.