NCircle NTSE-022115-UDH

GUDID 00827002187788

NCircle, Nitinol Tipless Stone Extractor

COOK INCORPORATED

Biliary/urinary stone retrieval basket, single-use

• Primary Device ID: 00827002187788
• NIH Device Record Key: 8e3d28c0-a687-45f5-abf1-a8bb00d96bfc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NCircle
• Version Model Number: G18778
• Catalog Number: NTSE-022115-UDH
• Company DUNS: 042823948
• Company Name: COOK INCORPORATED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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

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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00827002187788 [Primary]

FDA Product Code

• FFL: DISLODGER, STONE, BASKET, URETERAL, METAL

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: 2020-05-06
• Device Publish Date: 2016-09-24

On-Brand Devices [NCircle]

• 00827002496200: NCircle, Nitinol Tipless Stone Extractor
• 00827002462069: NCircle, Nitinol Tipless Stone Extractor
• 00827002237971: NCircle, Tipless Salivary Stone Extractor
• 00827002191112: NCircle, Nitinol Tipless Stone Extractor Modified Delta Wire, Basket
• 00827002191105: NCircle, Nitinol Tipless Stone Extractor Delta Wire, Basket
• 00827002187788: NCircle, Nitinol Tipless Stone Extractor
• 00827002187771: NCircle, Nitinol Tipless Stone Extractor Modified Basket
• 00827002181939: NCircle, Nitinol Tipless Helical Stone Extractor
• 00827002181915: NCircle, Nitinol Tipless Helical Stone Extractor
• 00827002178724: NCircle, Nitinol Tipless Stone Extractor Modified Basket
• 00827002176805: NCircle Nitinol Tipless Stone Extractor
• 00827002176270: NCircle, Nitinol Tipless Stone Extractor
• 00827002175204: NCircle, Nitinol Tipless Stone Extractor
• 00827002187382: NCircle Hysteroscopic Polyp Snare