FDA.reportPublic FDA data

CanGaroo Envelope

Primary DI
00859389005027
Brand
CanGaroo Envelope
Company
Elutia Med LLC
Model
CMCV-009-SML
Device description
The CanGaroo® Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo® Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo® Envelope include vagus nerve stimulators, spinal cordneuromodulators, deep brain stimulators and sacral nerve stimulators.
Published
2015-07-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
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
10859389005024PackageGS15In Commercial Distribution
00859389005027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085938900502410859389005024
00859389005027008593890050278593890050270859389005027

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

Contacts#

Phone, Email table
PhoneEmail
470-514-4080xxx@xx.xx

Regulatory Flags#

DUNS number
080924060
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859389005331EluPro Antibiotic-Eluting BioEnvelopeCMCV-124-MED2024-09-06
00859389005348EluPro Antibiotic-Eluting BioEnvelopeCMCV-124-LRG2024-09-06
00859389005010ProxiCor for Pericardial ClosureCMCV-060-4022015-06-30
00859389005034CanGaroo EnvelopeCMCV-009-MED2015-07-01
00859389005041ProxiCor for Cardiac Tissue RepairCMCV-064-4012015-06-30
00859389005058ProxiCor for Cardiac Tissue RepairCMCV-067-4042015-07-01
00859389005065CanGaroo EnvelopeCMCV-009-LRG2015-07-01
00859389005072CanGaroo EnvelopeCMCV-009-XLG2015-07-01
00859389005089VasCure for Carotid RepairCMCV-072-6062015-07-01
00859389005096VasCure for Carotid RepairCMCV-073-6092015-07-01
00859389005102Tyke, Patch, Pledget and IntracardiacCMCV-098-2042019-02-28
00859389005119CanGaroo EnvelopeCMCV-009-XXL2019-02-28
00859389005126VasCure for Vascular RepairCMCV-011-6062015-07-01
00859389005140VasCure for Vascular RepairCMCV-013-6092015-07-01
04035479160555Biotronik BioEnvelope4405792019-08-26
04035479160517Biotronik BioEnvelope4405752019-08-26
04035479160524Biotronik BioEnvelope4405762019-08-26
04035479160531Biotronik BioEnvelope4405772019-08-26
04035479160548Biotronik BioEnvelope4405782019-08-26
00859389005003ProxiCor for Pericardial ClosureCMCV-059-4012015-04-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00802526629914CanGaroo®Boston Scientific CorporationFTM2026-05-27
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00802526629938CanGaroo®Boston Scientific CorporationFTM2026-05-27
00802526629945CanGaroo®Boston Scientific CorporationFTM2026-05-27
00802526630002EluPro™Boston Scientific CorporationFTM2026-05-27
00802526630019EluPro™Boston Scientific CorporationFTM2026-05-27
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