Gelsoft Plus™ 691008BP

GUDID 05037881115832

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

VASCUTEK LTD

Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft

• Primary Device ID: 05037881115832
• NIH Device Record Key: 9e2bf3fb-0534-48a8-bcc5-2b7dbb363262
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gelsoft Plus™
• Version Model Number: 691008BP
• Catalog Number: 691008BP
• Company DUNS: 229053087
• Company Name: VASCUTEK LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com

Device Dimensions

• Length: 90 Centimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Length: 90 Centimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Length: 90 Centimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Length: 90 Centimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Length: 90 Centimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Length: 90 Centimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Length: 90 Centimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Length: 90 Centimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Length: 90 Centimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Length: 90 Centimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Length: 90 Centimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Length: 90 Centimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Length: 90 Centimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Length: 90 Centimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Length: 90 Centimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Length: 90 Centimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 10 Millimeter
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05037881115832 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202703

FDA Product Code

• DSY: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-22
• Device Publish Date: 2021-04-14

On-Brand Devices [Gelsoft Plus™]

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• 05037881998497: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis AX-BIFEM ERS REINFORCED
• 05037881115818: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT
• 05037881115801: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis AX-BIFEM EQUI-FLO ERS REINFORCED
• 05037881115795: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis AX-BIFEM EQUI-FLO ERS REINFORCED
• 05037881115788: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis AX-BIFEM EQUI-FLO ERS REINFORCED
• 05037881115771: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis AX-BIFEM EQUI-FLO ERS REINFORCED
• 05037881115764: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis AX-BIFEM ERS REINFORCED
• 05037881115757: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis AX-BIFEM ERS REINFORCED
• 05037881115740: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis FEM-FEM ERS CENTRALLY REINFORCED
• 05037881115733: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis FEM-FEM ERS CENTRALLY REINFORCED
• 05037881115726: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis FEM-FEM ERS CENTRALLY REINFORCED
• 05037881115719: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis FEM-FEM ERS CENTRALLY REINFORCED
• 05037881115702: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT ERS REINFORCED
• 05037881115696: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT ERS REINFORCED
• 05037881115689: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT ERS REINFORCED
• 05037881115672: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT ERS REINFORCED
• 05037881115665: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT ERS REINFORCED
• 05037881115627: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis AX-BIFEM RIGHT BRANCH
• 05037881115610: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis AX-BIFEM LEFT BRANCH
• 05037881115603: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis AX-BIFEM RIGHT BRANCH
• 05037881115597: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT
• 05037881115580: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT
• 05037881115573: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT
• 05037881115566: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE
• 05037881115559: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE
• 05037881115542: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE
• 05037881115535: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE
• 05037881115528: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE
• 05037881115511: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE
• 05037881115504: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE
• 05037881115481: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis EXTRA LENGTH BIFURCATE
• 05037881115474: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis EXTRA LENGTHBIFURCATE
• 05037881115467: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis EXTRA LENGTH BIFURCATE
• 05037881115450: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis EXTRA LENGTH BIFURCATE BIFURCATE
• 05037881115443: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis EXTRA LENGTH BIFURCATE
• 05037881115436: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis EXTRA LENGTH BIFURCATE
• 05037881115429: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis EXTRA LENGTH BIFURCATE
• 05037881115412: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT
• 05037881115405: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT
• 05037881115399: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT
• 05037881115382: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT
• 05037881115375: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT
• 05037881115368: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT
• 05037881115351: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT
• 05037881115344: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT
• 05037881115337: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT
• 05037881115320: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT
• 05037881115313: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT
• 05037881115306: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT