Duns Number:809699023
Device Description: Polycarbonate Syringe 6mL
Catalog Number
-
Brand Name
NAMIC
Version/Model Number
70127467
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K140194,K140194
Product Code
FMF
Product Code Name
Syringe, piston
Public Device Record Key
befc1d14-7180-4206-84c8-75d1ebdd3b0f
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 20, 2016
Package DI Number
H965701274671
Quantity per Package
25
Contains DI Package
H965701274670
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 71 |
2 | A medical device with a moderate to high risk that requires special controls. | 1641 |