Duns Number:001618818
Device Description: Interchangeable 10mL in 1/5mL, Glass Tip
Catalog Number
5029
Brand Name
MICRO-MATE®
Version/Model Number
5029
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 30, 2019
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
-
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
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
48756ab0-4e73-4fc0-a6fd-b26aa60c5e2a
Public Version Date
February 27, 2020
Public Version Number
4
DI Record Publish Date
September 20, 2016
Package DI Number
00816329020267
Quantity per Package
12
Contains DI Package
00816329020298
Package Discontinue Date
November 30, 2019
Package Status
Not in Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 59 |