droplet® pen needle - 100 pcs sterile, single use droplet® pen needles - HTL STREFA S A

Duns Number:422528088

Device Description: 100 pcs sterile, single use droplet® pen needles per box, intended to be used with a pen i 100 pcs sterile, single use droplet® pen needles per box, intended to be used with a pen injector device for the subcutaneous injection of insulin or drugs

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More Product Details

Catalog Number

8315

Brand Name

droplet® pen needle

Version/Model Number

32G x 4mm

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

Yes

FDA Premarket Submission

-

Product Code Details

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Device Record Status

Public Device Record Key

e857db9f-0a2d-4ad7-8b9d-9ba7a304663a

Public Version Date

December 08, 2020

Public Version Number

6

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

15907996092694

Quantity per Package

30

Contains DI Package

05907996092697

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

shipping 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