Duns Number:088013219
Catalog Number
-
Brand Name
Medic Anti-stick Needle/Connector
Version/Model Number
M8-5007
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
c39537c2-7e99-44ce-822e-066b9549d43d
Public Version Date
October 20, 2020
Public Version Number
1
DI Record Publish Date
October 12, 2020
Package DI Number
10842289102603
Quantity per Package
4
Contains DI Package
00842289102606
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipping Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 211 |