Duns Number:002348191
Device Description: PLEDGET SOFT 1/2 INCHES X 6 INCHES X 1/16 INCHES X 1
Catalog Number
EX-6500
Brand Name
DEKNATEL
Version/Model Number
IPN029123
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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"
Yes
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
K153089,K153089,K153089
Product Code
DXZ
Product Code Name
PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
Public Device Record Key
3a1f9ced-7ca6-4882-8185-1e8b707c8b0c
Public Version Date
July 16, 2021
Public Version Number
7
DI Record Publish Date
December 03, 2018
Package DI Number
34026704638636
Quantity per Package
12
Contains DI Package
14026704638632
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |