Duns Number:079241502
Device Description: Syringe 3 ml LL, 25G x 5/8"
Catalog Number
-
Brand Name
Doctors Choice
Version/Model Number
S325625SN1
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"
Yes
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
52e973ea-0866-43b8-9400-841a90f617ba
Public Version Date
January 19, 2021
Public Version Number
1
DI Record Publish Date
January 11, 2021
Package DI Number
G018S325625SN11
Quantity per Package
100
Contains DI Package
G018S325625SN10
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. | 1 |