Thinwall 921015T
GUDID 05037881010885
Thin Wall Carotid Patch Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
VASCUTEK LTD
Cardiovascular patch, animal-derived| Primary Device ID | 05037881010885 |
| NIH Device Record Key | 6c5a09f5-6107-482c-b4ac-7ff0f8568525 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Thinwall |
| Version Model Number | 921015T |
| Catalog Number | 921015T |
| 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 |
| 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. |
| 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 | 05037881010885 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
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 | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-03-24 |
| Device Publish Date | 2015-10-22 |
On-Brand Devices [Thinwall]
| 05037881999227 | Thin Wall Carotid Patch Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED NO BLACK LIN |
| 05037881010892 | Thin Wall Carotid Patch Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH |
| 05037881010885 | Thin Wall Carotid Patch Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH |
| 05037881010878 | Thin Wall Carotid Patch Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH |
| 05037881010861 | Thin Wall Carotid Patch Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH |
| 05037881010854 | Thin Wall Carotid Patch Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH |
| 05037881010847 | Thin Wall Carotid Patch Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH |
| 05037881010830 | Thin Wall Carotid Patch Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH |
| 05037881010823 | Thin Wall Carotid Patch Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH |
| 05037881010816 | Thin Wall Carotid Patch Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH |
Trademark Results [Thinwall]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 THINWALL 72274986 0865964 Dead/Expired |
PRECISION PAPER TUBE COMPANY 1967-06-28 |
 THINWALL 72257744 0843957 Dead/Expired |
ADANLOCK JAMESTOWN CORPORATION 1966-11-02 |
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