Soehendra SBDC-11.5

GUDID 00827002220461

Soehendra Biliary Dilation Catheter

COOK INCORPORATED

Biliary drainage catheter

• Primary Device ID: 00827002220461
• NIH Device Record Key: 760891ee-3058-4c27-8aad-c856a02e918b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Soehendra
• Version Model Number: G22046
• Catalog Number: SBDC-11.5
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00827002220461 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171548

FDA Product Code

• FGE: Stents, drains and dilators for the biliary ducts

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: 2018-07-20
• Device Publish Date: 2018-06-19

On-Brand Devices [Soehendra]

• 00827002508002: Soehendra Biliary Dilation Catheter
• 00827002222052: Soehendra Stent Retriever
• 00827002220621: Soehendra Biliary Dilation Catheter
• 00827002220461: Soehendra Biliary Dilation Catheter
• 00827002219373: Soehendra Stent Retriever
• 00827002219342: Soehendra Stent Retriever
• 00827002218604: Soehendra Lithotriptor Handle
• 00827002217324: Soehendra Billroth II Sphincterotome
• 00827002217294: Soehendra Biliary Dilation Catheter
• 00827002216617: Soehendra Stent Retriever
• 00827002216044: Soehendra Lithotripsy Cable
• 00827002215764: Soehendra Biliary Dilation Catheter
• 00827002215733: Soehendra Biliary Dilation Catheter
• 00827002215719: Soehendra Biliary Dilation Catheter
• 00827002215689: Soehendra Biliary Dilation Catheter
• 00827002215351: Soehendra Stent Retriever