CryoValve® SG Pulmonary Human Heart Valve SGPV10

GUDID 00877234000454

Pulmonary Valve SG The CryoValve SG Pulmonary Human Heart Valve is a human heart valve aseptically recovered from donated human tissue.

Cryolife, Inc.

Cadaveric heart valve prosthesis, decellularized, non-sterile

• Primary Device ID: 00877234000454
• NIH Device Record Key: a8883b37-cc16-4a84-ada3-bf4b493723cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CryoValve® SG Pulmonary Human Heart Valve
• Version Model Number: SGPV10
• Catalog Number: SGPV10
• Company DUNS: 119253177
• Company Name: Cryolife, 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: true
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 770-419-3355
• Email: xxx@xx.xx
• Phone: 770-419-3355
• Email: xxx@xx.xx

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *At or Below -135 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *At or Below -135 degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00877234000454 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092021

FDA Product Code

• OHA: Heart Valve, More Than Minimally Manipulated Allograft

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-24
• Device Publish Date: 2015-09-11

On-Brand Devices [CryoValve® SG Pulmonary Human Heart Valve ]

• 00877234000454: Pulmonary Valve SG The CryoValve SG Pulmonary Human Heart Valve is a human heart valve aseptical
• 00877234000447: Pulmonary Valve and Conduit SG The CryoValve SG Pulmonary Human Heart Valve is a human heart val