Duns Number:529309049
Device Description: Sharp container, 2G
Catalog Number
-
Brand Name
Gongdong
Version/Model Number
SC-02G
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
MMK
Product Code Name
Container, Sharps
Public Device Record Key
de3140c3-94c5-4609-ab3c-d388f13a585b
Public Version Date
November 15, 2021
Public Version Number
3
DI Record Publish Date
August 19, 2020
Package DI Number
16947462492381
Quantity per Package
24
Contains DI Package
06947462492384
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 | 21 |
2 | A medical device with a moderate to high risk that requires special controls. | 12 |