FDA.reportPublic FDA data

Biotronik BioEnvelope

Primary DI
04035479160647
Brand
Biotronik BioEnvelope
Company
AZIYO BIOLOGICS, INC.
Model
440579
Device description
The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable devices that may be used with the BioEnvelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
Published
2019-08-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTMMesh, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTMMesh, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04035479160647PackageGS15In Commercial Distribution
04035479160555PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04035479160647040354791606474035479160647
04035479160555040354791605554035479160555

GMDN Terms#

Term, Definition table
TermDefinition
Cardiovascular patch, animal-derivedAn 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
470-514-4080customerservice@aziyo.com

Regulatory Flags#

DUNS number
080251450
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10859389005109Tyke, Patch, Pledget and IntracardiacCMCV-098-2042019-02-28
10859389005116CanGaroo EnvelopeCMCV-009-XXL2019-02-28
10859389005024CanGaroo EnvelopeCMCV-009-SML2015-07-01
10859389005031CanGaroo EnvelopeCMCV-009-MED2015-07-01
10859389005062CanGaroo EnvelopeCMCV-009-LRG2015-07-01
10859389005079CanGaroo EnvelopeCMCV-009-XLG2015-07-01
10859389005017ProxiCor for Pericardial ClosureCMCV-060-4022015-06-30
10859389005048ProxiCor for Cardiac Tissue RepairCMCV-064-4012015-06-30
10859389005055ProxiCor for Cardiac Tissue RepairCMCV-067-4042015-07-01
10859389005086VasCure for Carotid RepairCMCV-072-6062015-07-01
10859389005093VasCure for Carotid RepairCMCV-073-6092015-07-01
10859389005123VasCure for Vascular RepairCMCV-011-6062015-07-01
10859389005147VasCure for Vascular RepairCMCV-013-6092015-07-01

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