Duns Number:058614483
Device Description: Nonabsorbable Pre-punched Pledgets,5x Soft PTFE Pledgets 9.5x4.8x1.5mm
Catalog Number
-
Brand Name
PTFE Polymer Pledgets
Version/Model Number
88868679-01
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
K953289,K953289
Product Code
DXZ
Product Code Name
PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
Public Device Record Key
fd092e04-7c1e-4c3d-a26b-c4a32f1dd3a3
Public Version Date
April 08, 2022
Public Version Number
6
DI Record Publish Date
August 31, 2015
Package DI Number
20884521104638
Quantity per Package
36
Contains DI Package
10884521104631
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |