droplet insulin syringe - droplet insulin syringe with fixed needle is a - HTL STREFA S A

Duns Number:422528088

Device Description: droplet insulin syringe with fixed needle is a sterile single use syringe for the injectio droplet insulin syringe with fixed needle is a sterile single use syringe for the injection of U-100 insulin only.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

6051

Brand Name

droplet insulin syringe

Version/Model Number

0.5ml, 29G x 12mm

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FMF

Product Code Name

Syringe, Piston

Device Record Status

Public Device Record Key

eb8e35d3-9c7d-44a8-9127-ce0051fc6558

Public Version Date

July 15, 2019

Public Version Number

1

DI Record Publish Date

July 07, 2019

Additional Identifiers

Package DI Number

05907996097906

Quantity per Package

10

Contains DI Package

05907996097876

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box

"HTL STREFA S A" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2