Duns Number:797372554
Device Description: 1mL x 25G 5/8"
Catalog Number
-
Brand Name
NIPRO DISPOSABLE SYRINGE
Version/Model Number
JD+01T2516-WEI
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
FMF
Product Code Name
Syringe, piston
Public Device Record Key
48456ea6-37b5-44cf-b3df-0aab65a4ffbd
Public Version Date
September 12, 2018
Public Version Number
2
DI Record Publish Date
March 01, 2018
Package DI Number
10383790008256
Quantity per Package
200
Contains DI Package
00383790008259
Package Discontinue Date
-
Package Status
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. | 230 |