AccessGUDID - DEVICE: Tyke, Patch, Pledget and Intracardiac (00859389005102)

GUDID

Device Identifier (DI) Information

Brand Name: Tyke, Patch, Pledget and Intracardiac
Version or Model: CMCV-098-204
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AZIYO BIOLOGICS, INC.

Primary DI Number: 00859389005102
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080251450 *Terms of Use

Device Description: Tyke is intended for use in neonates and infants for repair of pericardial structures, as an epicardial covering for damaged or repaired cardiac structures, as a patch material for intracardiac defects, septal defect and annulus repair, suture-line buttressing, and cardiac repair.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K152127	000

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
Storage Environment Temperature: between 10 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Height: 4 Centimeter
Width: 7 Centimeter

Device Record Status

Public Device Record Key: c8709cb5-e244-44be-8415-8acfa66ba448
Public Version Date: February 05, 2021
Public Version Number: 2
DI Record Publish Date: February 28, 2019