Intra-Art Coronary Artery Retraction Clip

GUDID B040CRC32

Coronary Artery Retraction Clip

GENESEE BIOMEDICAL, INC.

Coronary artery exposure retractor

• Primary Device ID: B040CRC32
• NIH Device Record Key: da6cc898-177c-4934-a719-f443e4afe451
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Intra-Art Coronary Artery Retraction Clip
• Version Model Number: CRC-3
• Company DUNS: 939872651
• Company Name: GENESEE BIOMEDICAL, INC.
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800 786-4890
• Email: info@geneseebiomedical.com
• Phone: 800 786-4890
• Email: info@geneseebiomedical.com

Device Dimensions

• Length: 3 Millimeter
• Length: 3 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B040CRC31 [Primary]
HIBCC	B040CRC32 [Package]; Contains: B040CRC31; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K882981

FDA Product Code

• DWS: Instruments, Surgical, Cardiovascular

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: 2018-07-06
• Device Publish Date: 2017-02-01

On-Brand Devices [Intra-Art Coronary Artery Retraction Clip]

• B040CRC52: Coronary Artery Retraction Clip
• B040CRC32: Coronary Artery Retraction Clip