Duns Number:001483130
Device Description: Chex-All® II Instant-Seal Pouches - 8 x 16" - Steam or EO - 1 Case of 250
Catalog Number
02401400
Brand Name
Propper Chex-All Sterilization Pouches
Version/Model Number
02401400
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FRG
Product Code Name
Wrap, Sterilization
Public Device Record Key
1fb4ac65-54e7-4c18-a96c-1bd9fa3be4f1
Public Version Date
November 08, 2019
Public Version Number
3
DI Record Publish Date
October 10, 2017
Package DI Number
30818087010062
Quantity per Package
125
Contains DI Package
10818087010068
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 58 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 49 |