Duns Number:080194935
Device Description: Self-Seal Sterilization Pouches 200/Bx 2.25"x4"
Catalog Number
-
Brand Name
3D Dental-Kangaroo
Version/Model Number
SP2X4
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)
Yes
Over the Counter (OTC)
Yes
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
029afe4b-6b64-40c4-9f2f-69cd2805ab75
Public Version Date
November 08, 2019
Public Version Number
3
DI Record Publish Date
December 14, 2016
Package DI Number
00817169021223
Quantity per Package
12
Contains DI Package
00817169021162
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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 142 |
| U | Unclassified | 1 |