Duns Number:190377184
Device Description: Autoclave Pouches 2 3/4" x 9", Dual Indicator (200pcs/box)
Catalog Number
POH234-9
Brand Name
Plasdent Clear Protection Sterilization Pouch
Version/Model Number
POH
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K172280,K172280,K172280,K172280
Product Code
FRG
Product Code Name
Wrap, Sterilization
Public Device Record Key
2385990c-0b72-4b66-8ed4-58fa404e273d
Public Version Date
February 22, 2022
Public Version Number
3
DI Record Publish Date
September 24, 2018
Package DI Number
D832POH23495
Quantity per Package
4000
Contains DI Package
D832POH2349
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 | 750 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 36 |