Duns Number:529309049
Device Description: Sharps Container, Rotary +Ype closure 3L
Catalog Number
-
Brand Name
Gongdong
Version/Model Number
GDC-03-X
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
07ff967e-54d7-4b0f-b58d-91d86918b719
Public Version Date
August 15, 2022
Public Version Number
1
DI Record Publish Date
August 05, 2022
Package DI Number
16947462492701
Quantity per Package
48
Contains DI Package
06947462492704
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton
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 |