Duns Number:002144145
Device Description: PDS PLATE VIO 0.5X50X40MM RECTANGULAR
Catalog Number
ZX6U
Brand Name
PDS Plates
Version/Model Number
ZX6U
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
K092590
Product Code
NHB
Product Code Name
POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE
Public Device Record Key
fc2705bc-a954-4b39-b771-dc1336c79ad2
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
June 15, 2017
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1128 |
| 3 | A medical device with high risk that requires premarket approval | 4 |
| U | Unclassified | 1 |