Duns Number:002144145
Device Description: PDS PLATE VIO 0.25X30X40MM SHAPED
Catalog Number
ZX3
Brand Name
PDS Plates
Version/Model Number
ZX3
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,K092590
Product Code
NHB
Product Code Name
POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE
Public Device Record Key
6b5edc1d-0a31-40bd-b29c-0567d55940a2
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
June 14, 2017
Package DI Number
20705031087931
Quantity per Package
3
Contains DI Package
10705031087934
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 | 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 |