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
36502-01
Brand Name
CardioWrap®
Version/Model Number
100 x 130 x 0.05mm
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 10, 2020
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,K031785
Product Code
OMH
Product Code Name
Pericardial Patch To Facilitate Revision Surgeries
Public Device Record Key
3939aa92-b7ea-4796-8006-42119ffb31bc
Public Version Date
June 10, 2022
Public Version Number
6
DI Record Publish Date
October 23, 2015
Package DI Number
18964050365023
Quantity per Package
5
Contains DI Package
08964050365026
Package Discontinue Date
November 10, 2020
Package Status
Not in Commercial Distribution
Package Type
5 unit box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |