Gelseal™ 43200877/10
GUDID 05037881101064
Gelseal Gelatin Impregnated Knitted Vascular Prosthesis
VASCUTEK LTD
Synthetic vascular graft| Primary Device ID | 05037881101064 |
| NIH Device Record Key | 2a1d9c9c-6a06-4e8d-bee0-4fdef6052625 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gelseal™ |
| Version Model Number | 43200877/10 |
| Catalog Number | 43200877/10 |
| 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
| Lumen/Inner Diameter | 20 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 20 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 20 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 20 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 20 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 20 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 20 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 20 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 20 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 20 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. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05037881101064 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K162803
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 | 2019-03-11 |
| Device Publish Date | 2019-02-20 |
On-Brand Devices [Gelseal™]
| 05037881101330 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT |
| 05037881101262 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT ERT REINFORCED |
| 05037881101255 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT ERT REINFORCED |
| 05037881101248 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT ERT REINFORCED |
| 05037881101231 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT ERT REINFORCED |
| 05037881101224 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT ERT REINFORCED |
| 05037881101194 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis AX-BIFEM LEFT BRANCH |
| 05037881101118 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis |
| 05037881101064 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis |
| 05037881101057 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis |
| 05037881101002 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis |
| 05037881100999 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis 4 BRANCH PLEXUS |
| 05037881100982 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis |
| 05037881100975 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis |
| 05037881100968 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis 4 BRANCH PLEXUS |
| 05037881100951 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis |
| 05037881100944 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis |
| 05037881100937 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis 4 BRANCH PLEXUS |
| 05037881100920 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis |
| 05037881100913 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis |
| 05037881100906 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis |
| 05037881100890 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis |
| 05037881100883 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis 3 BRANCH PLEXUS |
| 05037881100876 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis |
| 05037881100869 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis |
| 05037881100852 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis |
| 05037881100821 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis |
| 05037881100685 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis ANTE-FLO |
| 05037881100678 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis ANTE-FLO |
| 05037881100661 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis ANTE-FLO |
| 05037881100654 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis ANTE-FLO |
| 05037881100647 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis |
| 05037881100630 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis |
| 05037881100623 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis ANTE-FLO |
| 05037881100616 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis ANTE-FLO |
| 05037881100609 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis ANTE-FLO |
| 05037881100593 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis ANTE-FLO |
| 05037881100586 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis ANTE-FLO |
| 05037881100579 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis |
| 05037881100562 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE |
| 05037881100555 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE |
| 05037881100548 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE |
| 05037881100531 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE |
| 05037881100524 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE |
| 05037881100517 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE |
| 05037881100500 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis 4 BRANCH PLEXUS |
| 05037881100494 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE |
| 05037881100487 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT |
| 05037881100470 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT |
| 05037881100463 | Gelseal Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT |
Trademark Results [Gelseal]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GELSEAL 86278054 not registered Dead/Abandoned |
Connolly, Phillip 2014-05-12 |
 GELSEAL 85359435 4240184 Live/Registered |
Applied Medical Resources Corporation 2011-06-29 |
 GELSEAL 85010606 not registered Dead/Abandoned |
TYR Sport, Inc. 2010-04-09 |
 GELSEAL 79161619 5173434 Live/Registered |
Vascutek Limited 2014-10-02 |
 GELSEAL 78777862 3201179 Dead/Cancelled |
WELCH ALLYN, INC. 2005-12-21 |
 GELSEAL 76333044 2843520 Dead/Cancelled |
APPLIED MEDICAL RESOURCES CORPORATION 2001-11-01 |
 GELSEAL 75936741 not registered Dead/Abandoned |
Banner Pharmacaps, Inc. 2000-03-06 |
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