Duns Number:372587696
Device Description: Polymer Pledget PTFE Suture Butress
Catalog Number
PCP40
Brand Name
ETHICON
Version/Model Number
PCP40
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
-
Product Code
DXZ
Product Code Name
PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
Public Device Record Key
b66a3d23-7d01-431f-a685-aa99cb3f4067
Public Version Date
July 24, 2019
Public Version Number
3
DI Record Publish Date
September 01, 2015
Package DI Number
20705031047829
Quantity per Package
36
Contains DI Package
10705031047822
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 84 |