Biodesign C-FP-0.4

GUDID 10827002542010

Biodesign Fistula Plug

COOK BIOTECH INCORPORATED

Fistula-repair biomatrix implant

• Primary Device ID: 10827002542010
• NIH Device Record Key: 5505c17e-97eb-47d5-ae7a-7803e1116872
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biodesign
• Version Model Number: G54201
• Catalog Number: C-FP-0.4
• Company DUNS: 945385862
• Company Name: COOK BIOTECH INCORPORATED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00827002542013 [Primary]
GS1	10827002542010 [Package]; Contains: 00827002542013; Package: BX [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062729

FDA Product Code

• FTM: Mesh, surgical

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: 2024-04-04
• Device Publish Date: 2024-03-27

On-Brand Devices [Biodesign]

• 00827002546141: Biodesign Fistula Plug
• 00827002546134: Biodesign Fistula Plug
• 00827002546127: Biodesign Fistula Plug
• 00827002542525: Biodesign Staple Line Reinforcement
• 00827002542518: Biodesign Staple Line Reinforcement
• 00827002536142: Biodesign Anal Fistula Plug
• 00827002525498: Biodesign Nipple Reconstruction Cylinder
• 00827002517462: Biodesign Staple Line Reinforcement
• 00827002508712: Biodesign Staple Line Reinforcement
• 00827002508705: Biodesign Staple Line Reinforcement
• 00827002508682: Biodesign Staple Line Reinforcement
• 00827002508675: Biodesign Staple Line Reinforcement
• 00827002508668: Biodesign Staple Line Reinforcement
• 00827002508651: Biodesign Staple Line Reinforcement
• 00827002506565: Biodesign Staple Line Reinforcement
• 00827002491274: Biodesign Nipple Reconstruction Cylinder
• 00827002491267: Biodesign Nipple Reconstruction Cylinder
• 00827002347908: Biodesign Nipple Reconstruction Cylinder
• 00827002347892: Biodesign Nipple Reconstruction Cylinder
• 00827002250079: Biodesign Staple Line Reinforcement
• 00827002250062: Biodesign Staple Line Reinforcement
• 00827002248274: Biodesign Staple Line Reinforcement
• 00827002236622: Biodesign Staple Line Reinforcement
• 00827002236547: Biodesign Enterocutaneous Fistula Plug
• 00827002236530: Biodesign Enterocutaneous Fistula Plug
• 00827002232013: Biodesign Staple Line Reinforcement
• 10827002583310: Tissue Graft
• 10827002583303: Tissue Graft
• 10827002583297: Tissue Graft
• 10827002583280: Tissue Graft
• 10827002583273: Tissue Graft
• 10827002583976: Biodesign Staple Line Reinforcement
• 10827002583969: Biodesign Staple Line Reinforcement
• 10827002476551: Biodesign Peyronie's Repair Graft
• 10827002476544: Biodesign Peyronie's Repair Graft
• 10827002138084: Biodesign 4-Layer Tissue Graft
• 10827002138077: Biodesign 4-Layer Tissue Graft
• 10827002138060: Biodesign 4-Layer Tissue Graft
• 10827002131160: Biodesign 4-Layer Tissue Graft
• 10827002128481: Biodesign 4-Layer Tissue Graft
• 10827002324371: Biodesign Dural Graft
• 10827002310923: Biodesign Dural Graft
• 10827002310916: Biodesign Dural Graft
• 10827002310909: Biodesign Dural Graft
• 00827002528666: Biodesign Plastic Surgery Matrix
• 00827002528673: Biodesign Plastic Surgery Matrix
• 00827002552678: Biodesign Hernia Graft
• 00827002552661: Biodesign Hernia Graft
• 00827002552654: Biodesign Hernia Graft
• 00827002528659: Biodesign Plastic Surgery Matrix