TruForm Annuloplasty Ring

GUDID B040TRH42

Annuloplasty Ri

GENESEE BIOMEDICAL, INC.

Mitral/tricuspid annuloplasty ring, open-surgery

• Primary Device ID: B040TRH42
• NIH Device Record Key: b8952c6a-56b5-4e00-a1cd-2a3ec73cc81d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TruForm Annuloplasty Ring
• Version Model Number: TRH-42
• Company DUNS: 939872651
• Company Name: GENESEE BIOMEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B040TRH42 [Package]; Contains: B040TRH420; Package: [1 Units]; In Commercial Distribution
HIBCC	B040TRH420 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202253

FDA Product Code

• KRH: Ring, Annuloplasty

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: 2024-12-12
• Device Publish Date: 2024-12-04

On-Brand Devices [TruForm Annuloplasty Ring]

• B040TRH42: Annuloplasty Ri
• B040TRH40: Annuloplasty Ri
• B040TRH38: Annuloplasty Ri
• B040TRH36: Annuloplasty Ri
• B040TRH34: Annuloplasty Ri
• B040TRH32: Annuloplasty Ri
• B040TRH30: Annuloplasty Ring
• B040TRH28: Annuloplasty Ring
• B040TFH26: Annuloplasty Ring
• B040TRH24: Annuloplasty Ring