Gelsoft Plus™ 650808P

GUDID 05037881115603

Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis AX-BIFEM RIGHT BRANCH

VASCUTEK LTD

Synthetic vascular graft

• Primary Device ID: 05037881115603
• NIH Device Record Key: 3eabefc7-f997-461f-ba50-5b4f3339f95e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gelsoft Plus™
• Version Model Number: 650808P
• Catalog Number: 650808P
• 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)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx

Device Dimensions

• Device Size Text, specify: 0
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Length: 100 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area. Prosthesis must be implanted within one month after removal from the foil pouch.
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area. Prosthesis must be implanted within one month after removal from the foil pouch.
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area. Prosthesis must be implanted within one month after removal from the foil pouch.
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area. Prosthesis must be implanted within one month after removal from the foil pouch.
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area. Prosthesis must be implanted within one month after removal from the foil pouch.
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area. Prosthesis must be implanted within one month after removal from the foil pouch.
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area. Prosthesis must be implanted within one month after removal from the foil pouch.
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area. Prosthesis must be implanted within one month after removal from the foil pouch.
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area. Prosthesis must be implanted within one month after removal from the foil pouch.
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry area. Prosthesis must be implanted within one month after removal from the foil pouch.
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05037881115603 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002007

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-22

On-Brand Devices [Gelsoft Plus™]

• 05037881999647: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis EXTRA LENGTH BIFURCATE BIFURCATE
• 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