Duns Number:825137818
Device Description: STERILIZATION POUCH 2.25 X 4
Catalog Number
9508203
Brand Name
Darby Dental Supply, LLC
Version/Model Number
9508203
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KCT
Product Code Name
Sterilization wrap containers, trays, cassettes & other accessories
Public Device Record Key
ee6839da-2455-49b9-88ae-60da7be55729
Public Version Date
November 08, 2019
Public Version Number
3
DI Record Publish Date
May 19, 2016
Package DI Number
20889813000650
Quantity per Package
12
Contains DI Package
10889813000653
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 | 1457 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 194 |
| U | Unclassified | 2 |