Tyke, Patch, Pledget and Intracardiac

GUDID 10859389005109

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.

AZIYO BIOLOGICS, INC.

Cardiovascular patch, animal-derived

Primary Device ID	10859389005109
NIH Device Record Key	c8709cb5-e244-44be-8415-8acfa66ba448
Commercial Distribution Status	In Commercial Distribution
Brand Name	Tyke, Patch, Pledget and Intracardiac
Version Model Number	CMCV-098-204
Company DUNS	080251450
Company Name	AZIYO BIOLOGICS, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Safe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	470-514-4080
Email	xxx@xx.xx
Phone	470-514-4080
Email	xxx@xx.xx
Phone	470-514-4080
Email	xxx@xx.xx
Phone	470-514-4080
Email	xxx@xx.xx
Phone	470-514-4080
Email	xxx@xx.xx
Phone	470-514-4080
Email	xxx@xx.xx
Phone	470-514-4080
Email	xxx@xx.xx
Phone	470-514-4080
Email	xxx@xx.xx
Phone	470-514-4080
Email	xxx@xx.xx
Phone	470-514-4080
Email	xxx@xx.xx
Phone	470-514-4080
Email	xxx@xx.xx
Phone	470-514-4080
Email	xxx@xx.xx
Phone	470-514-4080
Email	xxx@xx.xx
Phone	470-514-4080
Email	xxx@xx.xx
Phone	470-514-4080
Email	xxx@xx.xx
Phone	470-514-4080
Email	xxx@xx.xx
Phone	470-514-4080
Email	xxx@xx.xx
Phone	470-514-4080
Email	xxx@xx.xx
Phone	470-514-4080
Email	xxx@xx.xx
Phone	470-514-4080
Email	xxx@xx.xx
Phone	470-514-4080
Email	xxx@xx.xx
Phone	470-514-4080
Email	xxx@xx.xx
Phone	470-514-4080
Email	xxx@xx.xx
Phone	470-514-4080
Email	xxx@xx.xx
Phone	470-514-4080
Email	xxx@xx.xx
Phone	470-514-4080
Email	xxx@xx.xx
Phone	470-514-4080
Email	xxx@xx.xx
Phone	470-514-4080
Email	xxx@xx.xx
Phone	470-514-4080
Email	xxx@xx.xx

Device Dimensions

Width	7 Centimeter
Width	7 Centimeter
Height	4 Centimeter
Width	7 Centimeter
Height	4 Centimeter
Width	7 Centimeter
Height	4 Centimeter
Width	7 Centimeter
Height	4 Centimeter
Width	7 Centimeter
Height	4 Centimeter
Width	7 Centimeter
Height	4 Centimeter
Width	7 Centimeter
Height	4 Centimeter
Width	7 Centimeter
Height	4 Centimeter
Width	7 Centimeter
Height	4 Centimeter
Width	7 Centimeter
Height	4 Centimeter
Width	7 Centimeter
Height	4 Centimeter
Width	7 Centimeter
Height	4 Centimeter
Width	7 Centimeter
Height	4 Centimeter
Width	7 Centimeter
Height	4 Centimeter
Width	7 Centimeter
Height	4 Centimeter
Width	7 Centimeter
Height	4 Centimeter
Width	7 Centimeter
Height	4 Centimeter
Width	7 Centimeter
Height	4 Centimeter
Width	7 Centimeter
Height	4 Centimeter
Width	7 Centimeter
Height	4 Centimeter
Width	7 Centimeter
Height	4 Centimeter
Width	7 Centimeter
Height	4 Centimeter
Width	7 Centimeter
Height	4 Centimeter
Width	7 Centimeter
Height	4 Centimeter
Width	7 Centimeter
Height	4 Centimeter
Width	7 Centimeter
Height	4 Centimeter
Width	7 Centimeter

Operating and Storage Conditions

Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859389005102 [Primary]
GS1	10859389005109 [Package] Contains: 00859389005102 Package: Box [5 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K152127

FDA Product Code

DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2019-03-11
Device Publish Date	2019-02-28

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04035479160517 - Biotronik BioEnvelope	2021-02-05 The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implant
04035479160524 - Biotronik BioEnvelope	2021-02-05 The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implant
04035479160531 - Biotronik BioEnvelope	2021-02-05 The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implant
04035479160548 - Biotronik BioEnvelope	2021-02-05 The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implant
04035479160647 - Biotronik BioEnvelope	2021-02-05 The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implant
10859389005109 - Tyke, Patch, Pledget and Intracardiac	2019-03-11Tyke 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.
10859389005109 - Tyke, Patch, Pledget and Intracardiac	2019-03-11 Tyke is intended for use in neonates and infants for repair of pericardial structures, as an epicardial covering for damaged or