Primary Device ID | 05037881115467 |
NIH Device Record Key | 0b5b990e-5c01-4d59-859a-0881396e04b8 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Gelsoft Plus™ |
Version Model Number | 632010P50 |
Catalog Number | 632010P50 |
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 |
Phone | +1(800)262-3304 |
xx@xx.xx | |
Phone | +1(800)262-3304 |
xx@xx.xx | |
Phone | +1(800)262-3304 |
xx@xx.xx | |
Phone | +1(800)262-3304 |
xx@xx.xx | |
Phone | +1(800)262-3304 |
xx@xx.xx | |
Phone | +1(800)262-3304 |
xx@xx.xx | |
Phone | +1(800)262-3304 |
xx@xx.xx | |
Phone | +1(800)262-3304 |
xx@xx.xx | |
Phone | +1(800)262-3304 |
xx@xx.xx | |
Phone | +1(800)262-3304 |
xx@xx.xx | |
Phone | +1(800)262-3304 |
xx@xx.xx | |
Phone | +1(800)262-3304 |
xx@xx.xx | |
Phone | +1(800)262-3304 |
xx@xx.xx | |
Phone | +1(800)262-3304 |
xx@xx.xx | |
Phone | +1(800)262-3304 |
xx@xx.xx | |
Phone | +1(800)262-3304 |
xx@xx.xx | |
Phone | +1(800)262-3304 |
xx@xx.xx | |
Phone | +1(800)262-3304 |
xx@xx.xx | |
Phone | +1(800)262-3304 |
xx@xx.xx | |
Phone | +1(800)262-3304 |
xx@xx.xx | |
Phone | +1(800)262-3304 |
xx@xx.xx | |
Phone | +1(800)262-3304 |
xx@xx.xx | |
Phone | +1(800)262-3304 |
xx@xx.xx | |
Phone | +1(800)888-3786 |
tmccustomer.admin@terumomedical.com | |
Phone | +1(800)888-3786 |
tmccustomer.admin@terumomedical.com | |
Phone | +1(800)888-3786 |
tmccustomer.admin@terumomedical.com | |
Phone | +1(800)888-3786 |
tmccustomer.admin@terumomedical.com | |
Phone | +1(800)888-3786 |
tmccustomer.admin@terumomedical.com | |
Phone | +1(800)888-3786 |
tmccustomer.admin@terumomedical.com | |
Phone | +1(800)888-3786 |
tmccustomer.admin@terumomedical.com | |
Phone | +1(800)888-3786 |
tmccustomer.admin@terumomedical.com | |
Phone | +1(800)888-3786 |
tmccustomer.admin@terumomedical.com | |
Phone | +1(800)888-3786 |
tmccustomer.admin@terumomedical.com | |
Phone | +1(800)888-3786 |
tmccustomer.admin@terumomedical.com | |
Phone | +1(800)888-3786 |
tmccustomer.admin@terumomedical.com |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
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. |
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. |
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 Issuing Agency | Device ID |
---|---|
GS1 | 05037881115467 [Primary] |
DSY | PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2019-02-19 |
Device Publish Date | 2015-10-19 |
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 |