Gelsoft™ 691008A
GUDID 05037881110721
Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis AX-BIFEM EQUI-FLO ERS REINFORCED
VASCUTEK LTD
Synthetic vascular graft| Primary Device ID | 05037881110721 |
| NIH Device Record Key | 61ff16ab-af5b-453b-add9-d9ccb852dc8d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gelsoft™ |
| Version Model Number | 691008A |
| Catalog Number | 691008A |
| 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)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 |
Device Dimensions
| Lumen/Inner Diameter | 10 Millimeter |
| Lumen/Inner Diameter | 10 Millimeter |
| Lumen/Inner Diameter | 10 Millimeter |
| Lumen/Inner Diameter | 10 Millimeter |
| Length | 90 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 10 Millimeter |
| Length | 90 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 10 Millimeter |
| Length | 90 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 10 Millimeter |
| Length | 90 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 10 Millimeter |
| Length | 90 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 10 Millimeter |
| Length | 90 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 10 Millimeter |
| Length | 90 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 10 Millimeter |
| Length | 90 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 10 Millimeter |
| Length | 90 Centimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 10 Millimeter |
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 | 05037881110721 [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 | 5 |
| Public Version Date | 2020-03-24 |
| Device Publish Date | 2015-10-19 |
On-Brand Devices [Gelsoft™]
| 05037881999463 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis VS040 BIFURCATE WITH SINGLE SIDE BRANCH |
| 05037881999456 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis VS040 BIFURCATE WITH DOUBLE SIDE BRANCHE |
| 05037881999449 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE |
| 05037881110820 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE |
| 05037881110813 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE |
| 05037881110806 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE |
| 05037881110790 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE |
| 05037881110783 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE |
| 05037881110776 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis AX-BIFEM EQUI-FLO ERS REINFORCED |
| 05037881110769 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis AX-BIFEM EQUI-FLO ERS REINFORCED |
| 05037881110752 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis AX-BIFEM EQUI-FLO ERS REINFORCED |
| 05037881110738 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis AX-BIFEM EQUI-FLO ERS REINFORCED |
| 05037881110721 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis AX-BIFEM EQUI-FLO ERS REINFORCED |
| 05037881110714 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis AX-BIFEM EQUI-FLO ERS REINFORCED |
| 05037881110707 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis AX-BIFEM ERS REINFORCED |
| 05037881110691 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis AX-BIFEM ERS REINFORCED |
| 05037881110684 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis FEM-FEM ERS CENTRALLY REINFORCED |
| 05037881110677 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis FEM-FEM ERS CENTRALLY REINFORCED |
| 05037881110660 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis FEM-FEM ERS CENTRALLY REINFORCED |
| 05037881110653 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis FEM-FEM ERS CENTRALLY REINFORCED |
| 05037881110646 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT ERS REINFORCED |
| 05037881110639 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT ERS REINFORCED |
| 05037881110622 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT ERS REINFORCED |
| 05037881110615 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT ERS REINFORCED |
| 05037881110608 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT ERS REINFORCED |
| 05037881110585 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis AX-BIFEM RIGHT BRANCH |
| 05037881110578 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis AX-BIFEM LEFT BRANCH |
| 05037881110561 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis AX-BIFEM RIGHT BRANCH |
| 05037881110554 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis AX-BIFEM LEFT BRANCH |
| 05037881110547 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis AX-BIFEM RIGHT BRANCH |
| 05037881110530 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT |
| 05037881110523 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT |
| 05037881110516 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT |
| 05037881110509 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE |
| 05037881110493 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE |
| 05037881110486 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE |
| 05037881110479 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE |
| 05037881110462 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE |
| 05037881110455 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE |
| 05037881110448 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE |
| 05037881110431 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT |
| 05037881110424 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT |
| 05037881110417 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT |
| 05037881110400 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT |
| 05037881110394 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT |
| 05037881110387 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT |
| 05037881110370 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT |
| 05037881110363 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT |
| 05037881110356 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT |
| 05037881110349 | Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT |
Trademark Results [Gelsoft]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GELSOFT 79311848 not registered Live/Pending |
CLARK CFP PTY LTD 2021-03-04 |
 GELSOFT 79298177 not registered Live/Pending |
DNA LEISURE HOLDINGS LIMITED 2020-09-04 |
 GELSOFT 79160115 4887242 Live/Registered |
Vascutek Limited 2014-10-02 |
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