Thinwall 920675TS

GUDID 05037881999227

Thin Wall Carotid Patch Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED NO BLACK LINE

VASCUTEK LTD

Cardiovascular patch, animal-derived

• Primary Device ID: 05037881999227
• NIH Device Record Key: e9f60e74-cd0c-4660-80c2-8d5ca9422b41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thinwall
• Version Model Number: 920675TS
• Catalog Number: 920675TS
• 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
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx

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

Operating and Storage Conditions

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05037881999227 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K963611

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: 3
• Public Version Date: 2018-07-06
• 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