Gelsoft™ Cardiovascular Patch 961001S
GUDID 05037881010663
Gelsoft Gelatin Impregnated Knitted Cardiovascular Patch
VASCUTEK LTD
Cardiovascular patch, animal-derived| Primary Device ID | 05037881010663 |
| NIH Device Record Key | ab3c1e64-4d70-4cc7-9319-416438b627f1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gelsoft™ Cardiovascular Patch |
| Version Model Number | 961001S |
| Catalog Number | 961001S |
| 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
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| 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. Vascutek Ltd Sealed Patches 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. Vascutek Ltd Sealed Patches 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. Vascutek Ltd Sealed Patches 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. Vascutek Ltd Sealed Patches 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. Vascutek Ltd Sealed Patches 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. Vascutek Ltd Sealed Patches 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. Vascutek Ltd Sealed Patches 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. Vascutek Ltd Sealed Patches 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. Vascutek Ltd Sealed Patches 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. Vascutek Ltd Sealed Patches 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. Vascutek Ltd Sealed Patches 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. Vascutek Ltd Sealed Patches 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. Vascutek Ltd Sealed Patches 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. Vascutek Ltd Sealed Patches 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. Vascutek Ltd Sealed Patches 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. Vascutek Ltd Sealed Patches 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. Vascutek Ltd Sealed Patches 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. Vascutek Ltd Sealed Patches 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. Vascutek Ltd Sealed Patches 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. Vascutek Ltd Sealed Patches 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. Vascutek Ltd Sealed Patches must be implanted within one month after removal from the foil pouch. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05037881010663 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K200955
FDA Product Code
| DXZ | PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE |
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 | 2020-07-24 |
| Device Publish Date | 2020-07-16 |
On-Brand Devices [Gelsoft™ Cardiovascular Patch]
| 05037881010618 | Gelsoft Gelatin Impregnated Knitted Cardiovascular Patch |
| 05037881010663 | Gelsoft Gelatin Impregnated Knitted Cardiovascular Patch |
| 05037881010649 | Gelsoft Gelatin Impregnated Knitted Cardiovascular Patch |
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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