Duns Number:051420107
Device Description: Sharps Stack 3Gal Red MMC
Catalog Number
-
Brand Name
Moore Medical
Version/Model Number
93270
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K942054,K942054
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
f7e34937-6a9b-433a-afc9-09a98f35ccee
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 09, 2016
Package DI Number
40607415001981
Quantity per Package
12
Contains DI Package
10607415001973
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 | 2 |
2 | A medical device with a moderate to high risk that requires special controls. | 4 |