AccessGUDID - DEVICE: CryoPatch® SG Pulmonary Human Cardiac Hemi-Artery Patch (00877234000461)

GUDID

Device Identifier (DI) Information

Brand Name: CryoPatch® SG Pulmonary Human Cardiac Hemi-Artery Patch
Version or Model: SGPH00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SGPH00
Company Name: Artivion, Inc.

Primary DI Number: 00877234000461
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119253177 *Terms of Use

Device Description: CryoPatch SG Pulmonary Hemi-Artery The CryoPatch SG Pulmonary Human Cardiac Patch 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?
61625	Cadaveric pulmonary artery bioprosthesis	An implantable heart tissue allograft obtained from a human cadaver intended to be implanted in the heart during open heart surgery, to be used for repair or reconstruction of a dysfunctional right ventricular outflow tract. It is aseptically processed, and treated to render the tissue decellularized. It may be supplied in various configurations including pulmonary hemi-artery, pulmonary trunk and pulmonary branch.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K101866	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: Branch Length: 1.0cm (minimum) (allograft specific)
Device Size Text, specify: Proximal Base: 30mm (minimum) (allograft specific)

Device Record Status

Public Device Record Key: 8ab8ec73-d465-49b0-bd60-1feea7c8ac16
Public Version Date: February 19, 2024
Public Version Number: 6
DI Record Publish Date: September 11, 2015