AccessGUDID - DEVICE: CryoValve® SG Pulmonary Human Heart Valve (00877234000454)

GUDID

Device Identifier (DI) Information

Brand Name: CryoValve® SG Pulmonary Human Heart Valve
Version or Model: SGPV10
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SGPV10
Company Name: Artivion, Inc.

Primary DI Number: 00877234000454
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119253177 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	Yes

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61626	Cadaveric heart valve prosthesis, decellularized, non-sterile	A non-sterile, implantable, allograft heart valve obtained from a human cadaver intended to be used to repair or replace a dysfunctional native or prosthetic heart valve in a patient. It is aseptically processed and treated to render the tissue decellularized. The device is typically used to treat acquired or congenital valvular disease and not intended to be sterilized prior to use.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
OHA	Heart Valve, More Than Minimally Manipulated Allograft

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K092021	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: At or Below -135 degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Internal Diameter: Ranges from 6mm to 32mm (allograft specific)

Device Record Status

Public Device Record Key: a8883b37-cc16-4a84-ada3-bf4b493723cc
Public Version Date: February 19, 2024
Public Version Number: 5
DI Record Publish Date: September 11, 2015