Duns Number:119253177
Device Description: CryoPatch SG Pulmonary TrunkThe CryoPatch SG Pulmonary Human Cardiac Patch is a human hear CryoPatch SG Pulmonary TrunkThe CryoPatch SG Pulmonary Human Cardiac Patch is a human heart valve aseptically recovered from donated human tissue.
Catalog Number
SGP010
Brand Name
CryoPatch® SG Pulmonary Human Cardiac Trunk Patch
Version/Model Number
SGP010
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
Yes
FDA Premarket Submission
K101866
Product Code
DXZ
Product Code Name
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Public Device Record Key
8b36a2c4-0ae9-4ef5-b2e7-7d57c34d9609
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
September 11, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 2 |