Cope ULT8.5-8.5-20-NUCL-A-RH

GUDID 00827002481701

Cope Nephroureterostomy Stent Ultrathane

COOK INCORPORATED

Nephrostomy catheter

• Primary Device ID: 00827002481701
• NIH Device Record Key: a56a7387-8f44-4eb9-a55e-8c549b7527f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cope
• Version Model Number: G48170
• Catalog Number: ULT8.5-8.5-20-NUCL-A-RH
• Company DUNS: 042823948
• Company Name: COOK INCORPORATED
• 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

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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00827002481701 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171603

FDA Product Code

• FAD: Stent, ureteral

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: 2020-05-21
• Device Publish Date: 2020-05-13

On-Brand Devices [Cope]

• 00827002102651: Cope Mandril Wire Guide Nitinol
• 00827002100770: Cope Mandril Wire Guide Stainless Steel
• 00827002097599: Cope Mandril Wire Guide Nitinol
• 00827002097476: Cope Mandril Wire Guide Nitinol
• 00827002096264: Cope Mandril Wire Guide Nitinol
• 00827002095939: Cope Mandril Wire Guide Stainless Steel
• 00827002095731: Cope Mandril Wire Guide Nitinol
• 00827002093959: Cope Mandril Wire Guide Nitinol
• 00827002093942: Cope Mandril Wire Guide Nitinol
• 00827002088610: Cope Mandril Wire Guide Nitinol
• 00827002087330: Cope Mandril Wire Guide Nitinol
• 00827002086876: Cope Mandril Wire Guide Nitinol
• 00827002086203: Cope Catheter Introduction System
• 00827002084308: Cope Mandril Wire Guide Nitinol
• 00827002084292: Cope Mandril Wire Guide Nitinol
• 00827002084285: Cope Mandril Wire Guide Nitinol
• 00827002084278: Cope Mandril Wire Guide Nitinol
• 00827002082762: Cope Pediatric Gastrointestinal Suture Anchor Set
• 00827002068988: Cope Proximal Biliary Loop Catheter Ultrathane
• 00827002067974: Cope Proximal Biliary Loop Catheter Ultrathane
• 00827002067561: Cope Proximal Biliary Loop Catheter Ultrathane,
• 00827002063198: Cope Gastrojejunostomy Cannula
• 00827002062191: Cope Mandril Wire Guide Stainless Steel
• 00827002058224: Cope Mandril Wire Guide Stainless Steel
• 00827002051867: Cope Mandril Wire Guide Stainless Steel
• 00827002051843: Cope Mandril Wire Guide Stainless Steel
• 00827002051836: Cope Mandril Wire Guide Stainless Steel
• 00827002051829: Cope Mandril Wire Guide Stainless Steel
• 00827002051812: Cope Mandril Wire Guide Stainless Steel
• 00827002051775: Cope Mandril Wire Guide Stainless Steel
• 00827002051768: Cope Mandril Wire Guide Stainless Steel
• 00827002046405: Cope Pediatric Gastrointestinal Suture
• 00827002046283: Cope Gastrointestinal Suture Anchor Set
• 00827002044746: Cope Gastrointestinal Suture Anchor Set
• 00827002034075: Cope Catheter Introduction System
• 00827002014923: Cope Introducing Dilator
• 00827002190795: Cope Mandril Wire Guide
• 00827002190788: Cope Mandril Wire Guide
• 00827002166226: Cope Mandril Wire Guide
• 00827002481831: Cope Nephroureterostomy Stent Ultrathane
• 00827002481824: Cope Nephroureterostomy Stent Ultrathane
• 00827002481800: Cope Nephroureterostomy Stent Ultrathane
• 00827002481794: Cope Nephroureterostomy Stent Ultrathane
• 00827002481763: Cope Nephroureterostomy Stent Ultrathane
• 00827002481756: Cope Nephroureterostomy Stent Ultrathane
• 00827002481732: Cope Nephroureterostomy Stent Ultrathane
• 00827002481725: Cope Nephroureterostomy Stent Ultrathane
• 00827002481718: Cope Nephroureterostomy Stent Ultrathane
• 00827002481701: Cope Nephroureterostomy Stent Ultrathane
• 00827002481688: Cope Nephroureterostomy Stent Ultrathane