Primary Device ID | 05037881015286 |
NIH Device Record Key | 545235c1-f17e-4a1e-9e48-e378a4c02b63 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Gelweave™ |
Version Model Number | 735020/8RMST |
Catalog Number | 735020/8RMST |
Company DUNS | 229053087 |
Company Name | VASCUTEK LTD |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Conditional |
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 |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Lumen/Inner Diameter | 20 Millimeter |
Length | 50 Centimeter |
Device Size Text, specify | 0 |
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. |
Device Issuing Agency | Device ID |
---|---|
GS1 | 05037881015286 [Primary] |
DSY | PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-03-11 |
Device Publish Date | 2019-02-20 |
05037881999968 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis 4 BRANCH PLEXUS |
05037881999951 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis 4 BRANCH PLEXUS |
05037881999906 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis ANGLED 4 BRANCH PLEXUS |
05037881999579 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis 4 BRANCH PLEXUS |
05037881999432 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis VALSALVA |
05037881999425 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis VALSALVA |
05037881999272 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis |
05037881999265 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis |
05037881998541 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis Longer Ante-Flo Offset Branch |
05037881998527 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis Longer Ante-Flo Offset Branch |
05037881998503 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis Longer Ante-Flo Offset Branch |
05037881998473 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis 4 BRANCH PLEXUS |
05037881998466 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis 4 BRANCH PLEXUS |
05037881998459 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis 4 BRANCH PLEXUS |
05037881998442 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis SIENA COLLARED 4 BRANCH PLEXUS |
05037881998435 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis 4 BRANCH PLEXUS |
05037881998343 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis PRECURVED 4 BRANCH PLEXUS |
05037881998336 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis PRECURVED 4 BRANCH PLEXUS |
05037881998329 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis PRECURVED 4 BRANCH PLEXUS |
05037881998312 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis PRECURVED 4 BRANCH PLEXUS |
05037881998305 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis PRECURVED 4 BRANCH PLEXUS |
05037881998299 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis PRECURVED 4 BRANCH PLEXUS |
05037881998282 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis PRECURVED 4 BRANCH PLEXUS |
05037881998275 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis PRECURVED 4 BRANCH PLEXUS |
05037881998213 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis VALSALVA |
05037881998206 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis LARGE BORE GELWEAVE |
05037881998190 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis LARGE BORE GELWEAVE |
05037881998183 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis AORTIC ARCH |
05037881998169 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis 4 BRANCH PLEXUS |
05037881998077 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis TRIFURCATE ARCH GRAFT |
05037881998060 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis TRIFURCATE ARCH GRAFT |
05037881998053 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis SIENA COLLARED ANTE-FLO WITH RADIOPAQUE M |
05037881998046 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis SIENA COLLARED ANTE-FLO WITH RADIOPAQUE M |
05037881998039 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis SIENA COLLARED ANTE-FLO WITH RADIOPAQUE M |
05037881998022 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis SIENA COLLARED ANTE-FLO WITH RADIOPAQUE M |
05037881998015 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis SIENA COLLARED ANTE-FLO WITH RADIOPAQUE M |
05037881998008 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis SIENA COLLARED ANTE-FLO WITH RADIOPAQUE M |
05037881997995 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis SIENA COLLARED ANTE-FLO WITH RADIOPAQUE M |
05037881997988 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis SIENA COLLARED ANTE-FLO WITH RADIOPAQUE M |
05037881997971 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis SIENA COLLARED ANTE-FLO WITH RADIOPAQUE M |
05037881997964 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis SIENA COLLARED ANTE-FLO WITH RADIOPAQUE M |
05037881997957 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis SIENA COLLARED ANTE-FLO WITH RADIOPAQUE M |
05037881997940 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis SIENA COLLARED ANTE-FLO WITH RADIOPAQUE M |
05037881997933 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis SIENA COLLARED ANTE-FLO WITH RADIOPAQUE M |
05037881997926 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis SIENA COLLARED ANTE-FLO WITH RADIOPAQUE M |
05037881997919 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis SIENA COLLARED ANTE-FLO WITH RADIOPAQUE M |
05037881997902 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis SIENA COLLARED ANTE-FLO WITH RADIOPAQUE M |
05037881997896 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis SIENA COLLARED 4 BRANCH PLEXUS WITH RADIO |
05037881997889 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis SIENA COLLARED 4 BRANCH PLEXUS |
05037881997872 | Gelweave Gelatin Impregnated Woven Vascular Prosthesis SIENA COLLARED 4 BRANCH PLEXUS |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
GELWEAVE 79144456 4705768 Live/Registered |
Vascutek Limited 2014-01-17 |