Primary Device ID | 10859389005024 |
NIH Device Record Key | 9722d9cd-27ab-4fa3-ab46-4b1db350b737 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CanGaroo Envelope |
Version Model Number | CMCV-009-SML |
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 |
Phone | 470-514-4080 |
xxx@xx.xx | |
Phone | 470-514-4080 |
xxx@xx.xx | |
Phone | 470-514-4080 |
xxx@xx.xx | |
Phone | 470-514-4080 |
xxx@xx.xx | |
Phone | 470-514-4080 |
xxx@xx.xx | |
Phone | 470-514-4080 |
xxx@xx.xx | |
Phone | 470-514-4080 |
xxx@xx.xx | |
Phone | 470-514-4080 |
xxx@xx.xx | |
Phone | 470-514-4080 |
xxx@xx.xx | |
Phone | 470-514-4080 |
xxx@xx.xx | |
Phone | 470-514-4080 |
xxx@xx.xx | |
Phone | 470-514-4080 |
xxx@xx.xx |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
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 Issuing Agency | Device ID |
---|---|
GS1 | 00859389005027 [Primary] |
GS1 | 10859389005024 [Package] Contains: 00859389005027 Package: Box [5 Units] In Commercial Distribution |
FTM | Mesh, Surgical |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 5 |
Public Version Date | 2019-03-06 |
Device Publish Date | 2015-07-01 |
10859389005116 | The CanGaroo® Envelope is intended to securely hold a cardiac implantable electronic device or |
10859389005079 | The CanGaroo® Envelope is intended to securely hold a cardiac implantable electronic device or |
10859389005062 | The CanGaroo® Envelope is intended to securely hold a cardiac implantable electronic device or |
10859389005031 | The CanGaroo® Envelope is intended to securely hold a cardiac implantable electronic device or |
10859389005024 | The CanGaroo® Envelope is intended to securely hold a cardiac implantable electronic device or |