AccessGUDID - DEVICE: Gelsoft Plus™ (05037881115832)

GUDID

Device Identifier (DI) Information

Brand Name: Gelsoft Plus™
Version or Model: 691008BP
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 691008BP
Company Name: VASCUTEK LTD

Primary DI Number: 05037881115832
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 229053087 *Terms of Use

Device Description: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis AX-BIFEM ERS REINFORCED

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35281	Synthetic vascular graft	An implantable artificial substitute for a blood vessel intended to replace or bypass a diseased or injured vessel, typically the aorta, an iliac, a femoral or popliteal artery; it is not intended for use in the coronary arteries. It is typically made of woven or knitted polyethylene terephthalate (Dacron) or polytetrafluoroethylene (PTFE) fabrics; it does not incorporate a metallic mesh (i.e., it is not a stent-graft).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
DSY	PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K202703	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
Length: 90 Centimeter
Device Size Text, specify: Branch length 40 cm
Lumen/Inner Diameter: 10 Millimeter
Device Size Text, specify: Branch diameter 8 mm

Device Record Status

Public Device Record Key: 9e2bf3fb-0534-48a8-bcc5-2b7dbb363262
Public Version Date: September 24, 2025
Public Version Number: 2
DI Record Publish Date: April 14, 2021