Duns Number:529309049
Device Description: Sharp Container, Flip+Ype closure 1L
Catalog Number
-
Brand Name
Gongdong
Version/Model Number
GDC-01-F
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
K082042,K082042
Product Code
MMK
Product Code Name
Container, Sharps
Public Device Record Key
46c26994-0502-471c-a287-5a87d8497646
Public Version Date
February 08, 2021
Public Version Number
1
DI Record Publish Date
January 31, 2021
Package DI Number
16947462491544
Quantity per Package
60
Contains DI Package
06947462491547
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 |