Duns Number:544543513
Device Description: 1ml luer lock syringe with needle 25GX1”.The syringes are intended to inject fluids into o 1ml luer lock syringe with needle 25GX1”.The syringes are intended to inject fluids into or withdraw fluids from the body.
Catalog Number
SNL12510
Brand Name
Numedico
Version/Model Number
1ML LL 25G*1
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"
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
K113091,K113091,K113091
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
5edd2b14-6cc1-4039-b504-cbde0c7395fc
Public Version Date
June 28, 2021
Public Version Number
1
DI Record Publish Date
June 19, 2021
Package DI Number
16971564465585
Quantity per Package
100
Contains DI Package
06971564465588
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-