Duns Number:542997182
Device Description: Sharps Container
Catalog Number
-
Brand Name
N/A
Version/Model Number
R3
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K101567,K101567
Product Code
MMK
Product Code Name
Container, Sharps
Public Device Record Key
84699a92-04c2-4538-b598-ec229db7b2d3
Public Version Date
May 31, 2022
Public Version Number
1
DI Record Publish Date
May 23, 2022
Package DI Number
16973696790085
Quantity per Package
30
Contains DI Package
06973696790088
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 6 |