Duns Number:188582360
Device Description: Bioresorbable protective sheet made from polylactide: a copolymer of 70:30 Poly(L-lactide- Bioresorbable protective sheet made from polylactide: a copolymer of 70:30 Poly(L-lactide-co-D,L-lactide). Indicated for use as a pericardium replacement device in patients that may require re-operation within six months.
Catalog Number
36504-01
Brand Name
CardioWrap
Version/Model Number
130 x 200 x 0.05mm
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)
-
FDA Premarket Submission
K031785
Product Code
OMH
Product Code Name
Pericardial Patch To Facilitate Revision Surgeries
Public Device Record Key
7e815bb3-a251-4789-8fc3-c472aa947270
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
November 11, 2020
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 |