Cook J-IAB-090023

GUDID 00827002303973

Intrauterine Access Balloon Catheter

COOK INCORPORATED

Intrauterine imaging medium catheter

• Primary Device ID: 00827002303973
• NIH Device Record Key: 8aca82a1-f97d-407d-8e39-a57afb6c48ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cook
• Version Model Number: G30397
• Catalog Number: J-IAB-090023
• Company DUNS: 042823948
• Company Name: COOK INCORPORATED
• 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: 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

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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00827002303973 [Primary]

FDA Product Code

• HES: INSUFFLATOR, CARBON-DIOXIDE, UTEROTUBAL (AND ACCESSORIES)
• LKF: Cannula, manipulator/injector, uterine

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

On-Brand Devices [Cook]

• 00827002155879: Hydrophilic Wire Guide With 1cm Flexible Tip
• 00827002155770: Hydrophilic Wire Guide With 1cm Flexible Tip
• 00827002155404: Urodynamic Balloon Catheter Triple Lumen
• 00827002155336: High Pressure Connecting Tube
• 00827002155305: Hydrophilic Wire Guide With Safe-T-J, Tip
• 00827002155008: Spiral Tip Ureteral Access Catheter
• 00827002154902: Hydrophilic Wire Guide
• 00827002154353: Urodynamics Catheter
• 00827002154346: Urodynamics Catheter
• 00827002154292: Urodynamics Catheter
• 00827002154254: Open-End Ureteral Catheter
• 00827002154247: Open-End Ureteral Catheter
• 00827002154230: Double Jaw Rat Tooth Forceps
• 00827002154223: Double Jaw Alligator Forceps
• 00827002152991: Endoscope Adapter For Laser Fiber
• 00827002152809: Movable Core Hydrophilic Wire Guide
• 00827002152786: Spherical Cup Biopsy Forceps
• 00827002152779: Elongated Cup Biopsy Forceps
• 00827002152564: Hydrophilic Wire Guide With 3cm Flexible Tip
• 00827002152540: Hydrophilic Wire Guide With 3cm Flexible Tip
• 00827002152526: Hydrophilic Wire Guide With 3cm Flexible Tip
• 00827002152489: Hydrophilic Wire Guide With 3cm Flexible Tip
• 00827002152458: Movable Core Hydrophilic Wire guide
• 00827002152434: Retrograde Urethrogram Catheter
• 00827002152397: Connecting Tube
• 00827002152373: Spherical Cup Biopsy Forceps
• 00827002152366: Elongated Cup Biopsy Forceps
• 00827002152359: Rat Tooth Forceps
• 00827002152304: Alligator Forceps With Flexible Shaft
• 00827002152250: Wire Guide With 3cm Flexible Tip
• 00827002152168: Open-End Ureteral Catheter
• 00827002152113: Mouse Tooth Forceps
• 00827002152106: Fascial Dilator Set
• 00827002151963: Fascial Dilator Set
• 00827002151956: Laser Ureteral Catheter
• 00827002151611: Pediatric Urethral Meatal Dilator
• 00827002151529: Flexible Ureteroscopy Introducer
• 00827002151130: Whistle Tip Ureteral Catheter (Right)
• 00827002151123: Whistle Tip Ureteral Catheter (Right)
• 00827002150942: Endoscopic Cap
• 00827002150881: Ureteral Dilator
• 00827002150676: PTFE Wire Guide With 3cm Flexible Tip
• 00827002150621: Female Urethral Dilation Balloon Catheter Set
• 00827002150614: Male Urethral Dilation Balloon Catheter Set
• 00827002150546: Cup Biopsy Forceps
• 00827002150454: Deflectable Brush Biopsy Set
• 10827002150369: Universal Ureteral Catheter
• 00827002150355: Pediatric Nephrostomy Stent Set
• 00827002150348: Pediatric Nephrostomy Stent Set
• 00827002150324: Flexible Ureteroscopy Introducer