D.A.S.H. DASH-35

GUDID 00827002541931

D.A.S.H. Dome Tip Double Lumen Sphincterotome

COOK INCORPORATED

Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

• Primary Device ID: 00827002541931
• NIH Device Record Key: 4f605f3a-da0d-46dc-a371-0b3525ca15c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: D.A.S.H.
• Version Model Number: G54193
• Catalog Number: DASH-35
• Company DUNS: 079720472
• 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

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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00827002541931 [Primary]

FDA Product Code

• KNS: Unit, electrosurgical, endoscopic (with or without accessories)

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: 2019-02-21
• Device Publish Date: 2016-09-24

On-Brand Devices [D.A.S.H.]

• 00827002541931: D.A.S.H. Dome Tip Double Lumen Sphincterotome
• 00827002268500: Howell D.A.S.H. Sphincterotome
• 00827002257900: Howell D.A.S.H. Sphincterotome
• 00827002256668: D.A.S.H. Dome Tip Double Lumen Sphincterotome
• 00827002256200: Howell D.A.S.H. Extraction Balloon with Multiple Sizing
• 00827002252271: Howell D.A.S.H. Direct Access System
• 00827002252257: Howell D.A.S.H. Direct Access System
• 00827002252240: Howell D.A.S.H. Sphincterotome
• 10827002347806: D.A.S.H. Preloaded with Acrobat Wire Guide
• 10827002347790: D.A.S.H. Preloaded with Acrobat Wire Guide
• 10827002347783: D.A.S.H. Preloaded with Acrobat Wire Guide