CardioCurve Steerable Sheath

GUDID 10851498007197

CIRCA SCIENTIFIC, LLC

Vascular guide-catheter, single-use

• Primary Device ID: 10851498007197
• NIH Device Record Key: 11f02cec-83b0-4149-b0e7-71431e7d696f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CardioCurve Steerable Sheath
• Version Model Number: CC-1040S
• Company DUNS: 963223222
• Company Name: CIRCA SCIENTIFIC, LLC
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10851498007197 [Primary]

FDA Product Code

• DYB: Introducer, Catheter

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: 2024-08-09
• Device Publish Date: 2024-08-01

On-Brand Devices [CardioCurve Steerable Sheath]

• 10851498007302: CC-1082L
• 10851498007296: CC-1082M
• 10851498007289: CC-1082S
• 10851498007272: CC-1071L
• 10851498007265: CC-1071M
• 10851498007258: CC-1071S
• 10851498007241: CC-1061L
• 10851498007234: CC-1061M
• 10851498007227: CC-1061S
• 10851498007210: CC-1040L
• 10851498007203: CC-1040M
• 10851498007197: CC-1040S