Gelweave™ 734028/10ADP
GUDID 05037881121031
Gelweave Gelatin Impregnated Woven Vascular Prosthesis VALSALVA ANTE-FLO
VASCUTEK LTD
Synthetic vascular graft| Primary Device ID | 05037881121031 |
| NIH Device Record Key | 86cd236a-eabc-4b8b-83b9-8e2a9d2f4049 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gelweave™ |
| Version Model Number | 734028/10ADP |
| Catalog Number | 734028/10ADP |
| 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 |
| 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 |
Device Dimensions
| Length | 40 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 28 Millimeter |
| Length | 40 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 28 Millimeter |
| Length | 40 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 28 Millimeter |
| Length | 40 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 28 Millimeter |
| Length | 40 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 28 Millimeter |
| Length | 40 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 28 Millimeter |
| Length | 40 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 28 Millimeter |
| Length | 40 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 28 Millimeter |
| Length | 40 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 28 Millimeter |
| Length | 40 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 28 Millimeter |
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 | 05037881121031 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K090987
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 | 2015-10-19 |
On-Brand Devices [Gelweave™]
| 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 |
Trademark Results [Gelweave]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GELWEAVE 79144456 4705768 Live/Registered |
Vascutek Limited 2014-01-17 |
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