Formula FORX414-14-135-7-12

GUDID 10827002569734

Formula 414 Rx, Renal Balloon-Expandable Stent

William Cook Europe ApS

Bare-metal renal artery stent

• Primary Device ID: 10827002569734
• NIH Device Record Key: 80f3a57b-10f2-4acf-91da-568017793ffb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Formula
• Version Model Number: G56973
• Catalog Number: FORX414-14-135-7-12
• Company DUNS: 305302119
• Company Name: William Cook Europe ApS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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
• 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.
• 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	10827002569734 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P100028

FDA Product Code

• NIN: STENT, RENAL

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-02-05
• Device Publish Date: 2014-09-24

On-Brand Devices [Formula]

• 10827002569758: Formula 414 Rx, Renal Balloon-Expandable Stent
• 10827002569741: Formula 414 Rx, Renal Balloon-Expandable Stent
• 10827002569734: Formula 414 Rx, Renal Balloon-Expandable Stent
• 10827002569727: Formula 414 Rx, Renal Balloon-Expandable Stent
• 10827002569710: Formula 414 Rx, Renal Balloon-Expandable Stent
• 10827002569703: Formula 414 Rx, Renal Balloon-Expandable Stent
• 10827002569697: Formula 414 Rx, Renal Balloon-Expandable Stent
• 10827002569680: Formula 414 Rx, Renal Balloon-Expandable Stent
• 10827002569673: Formula 414 Rx, Renal Balloon-Expandable Stent
• 10827002569666: Formula 414 Rx, Renal Balloon-Expandable Stent
• 10827002569659: Formula 414 Rx, Renal Balloon-Expandable Stent
• 10827002569642: Formula 414 Rx, Renal Balloon-Expandable Stent
• 10827002569635: Formula 414 Rx, Renal Balloon-Expandable Stent
• 10827002569628: Formula 414 Rx, Renal Balloon-Expandable Stent
• 10827002569611: Formula 414 Rx, Renal Balloon-Expandable Stent
• 10827002569604: Formula 414 Rx, Renal Balloon-Expandable Stent
• 10827002569598: Formula 414 Rx, Renal Balloon-Expandable Stent
• 10827002569581: Formula 414 Rx, Renal Balloon-Expandable Stent
• 10827002185286: Formula 414 Rx, Renal Balloon-Expandable Stent
• 10827002185279: Formula 414 Rx, Renal Balloon-Expandable Stent
• 10827002185262: Formula 414 Rx, Renal Balloon-Expandable Stent
• 10827002185255: Formula 414 Rx, Renal Balloon-Expandable Stent
• 10827002185248: Formula 414 Rx, Renal Balloon-Expandable Stent
• 10827002185231: Formula 414 Rx, Renal Balloon-Expandable Stent