Hercules HBDE-W-10-11-12

GUDID 00827002352681

Hercules 100 Transnasal Esophageal Balloon

COOK INCORPORATED

Gastrointestinal/biliary dilation balloon catheter, non-medicated

• Primary Device ID: 00827002352681
• NIH Device Record Key: a4180a3c-155d-4a83-9f29-777d4232672c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hercules
• Version Model Number: G35268
• Catalog Number: HBDE-W-10-11-12
• Company DUNS: 079720472
• 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
• 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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00827002352681 [Primary]

FDA Product Code

• KCF: DILATOR, ESOPHAGEAL, ENT

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: 2024-12-23
• Device Publish Date: 2022-12-20

On-Brand Devices [Hercules]

• 00827002517998: Hercules 3 Stage Wireguided Balloon Esophageal - Pyloric - Colonic
• 00827002517981: Hercules 3 Stage Wireguided Balloon Esophageal - Pyloric - Colonic
• 00827002517974: Hercules 3 Stage Wireguided Balloon Esophageal - Pyloric - Colonic
• 00827002517967: Hercules 3 Stage Wireguided Balloon Esophageal - Pyloric - Colonic
• 00827002517950: Hercules 3 Stage Wireguided Balloon Esophageal - Pyloric - Colonic
• 00827002487321: Hercules 3 Stage Balloon Esophageal
• 00827002319288: Hercules 3 Stage Balloon Esophageal
• 00827002319271: Hercules 3 Stage Balloon Esophageal
• 00827002319264: Hercules 3 Stage Balloon Esophageal
• 00827002319257: Hercules 3 Stage Balloon Esophageal
• 00827002352711: Hercules 100 Transnasal Esophageal Balloon
• 00827002352704: Hercules 100 Transnasal Esophageal Balloon
• 00827002352698: Hercules 100 Transnasal Esophageal Balloon
• 00827002352681: Hercules 100 Transnasal Esophageal Balloon
• 00827002352674: Hercules 100 Transnasal Esophageal Balloon