AccessGUDID - DEVICE: PhotoFix Decellularized Bovine Pericardium (00877234000539)

GUDID

Device Identifier (DI) Information

Brand Name: PhotoFix Decellularized Bovine Pericardium
Version or Model: PFP1X6
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PFP1X6
Company Name: Artivion, Inc.

Primary DI Number: 00877234000539
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119253177 *Terms of Use

Device Description: Decellularized Bovine Pericardium

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):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35273	Cardiovascular patch, animal-derived	An implantable material designed to reinforce suture lines and/or increase the strength of weak or injured cardiac and/or peripheral vascular tissues during cardiovascular repair/reconstruction procedures (e.g., annulus or septal defect repair, endarterectomy, profundaplasty). It is a patch made of, or coated/impregnated with, materials of animal origin (e.g., porcine, bovine, or equine pericardium/collagen), that is typically implanted with sutures.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
PSQ	Intracardiac Patch Or Pledget, Biologically Derived

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Do not place the pericardium in areas where significant temperature fluctuations occur.
Storage Environment Temperature: between 5 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Width: 1 Centimeter
Length: 6 Centimeter

Device Record Status

Public Device Record Key: a2a3b29f-7cae-4b1c-ab9c-9b8aea0d59a9
Public Version Date: February 19, 2024
Public Version Number: 4
DI Record Publish Date: January 19, 2018