SialoCath SDC-2.2-20

GUDID 00827002351660

SialoCath Salivary Duct Catheter

COOK INCORPORATED

Salivary irrigation catheter

• Primary Device ID: 00827002351660
• NIH Device Record Key: 64f1a5ff-5f45-47ef-b7a7-319a3a9fa388
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SialoCath
• Version Model Number: G35166
• Catalog Number: SDC-2.2-20
• Company DUNS: 042823948
• 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
• 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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00827002351660 [Primary]

FDA Product Code

• OAJ: catheter, drainage, intraoral/extraoral

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: 2020-10-12
• Device Publish Date: 2020-10-02

Devices Manufactured by COOK INCORPORATED

• 00827002352674 - Hercules: 2024-12-23 Hercules 100 Transnasal Esophageal Balloon
• 00827002352681 - Hercules: 2024-12-23 Hercules 100 Transnasal Esophageal Balloon
• 00827002352698 - Hercules: 2024-12-23 Hercules 100 Transnasal Esophageal Balloon
• 00827002352704 - Hercules: 2024-12-23 Hercules 100 Transnasal Esophageal Balloon
• 00827002352711 - Hercules: 2024-12-23 Hercules 100 Transnasal Esophageal Balloon
• 10827002346014 - Fusion: 2024-08-07 Fusion Omni Preloaded with Acrobat Wire Guide
• 10827002346939 - Fusion: 2024-08-07 Fusion Omni Preloaded with Acrobat Wire Guide
• 10827002347110 - Fusion: 2024-08-07 Fusion Omni Preloaded with Acrobat Wire Guide