MICRON, droplet pen needle 7915

GUDID 05907996096169

Sterile, single use MICRON, droplet pen needles, intended to be used with a pen injector device for the subcutaneous injection of insulin.

HTL STREFA S A

Autoinjector needle
Primary Device ID05907996096169
NIH Device Record Key470e447d-a644-48fe-a58d-9ecd0215a12e
Commercial Distribution StatusIn Commercial Distribution
Brand NameMICRON, droplet pen needle
Version Model Number34G x 3.5mm
Catalog Number7915
Company DUNS422528088
Company NameHTL STREFA S A
Device Count5
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1-770-528-0410
Emailinfo@mydroplet.com

Device Dimensions

Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 113 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS105907996096169 [Primary]
GS115907996096166 [Package]
Package: case [40 Units]
In Commercial Distribution
GS125907996096163 [Package]
Contains: 15907996096166
Package: shipper [12 Units]
In Commercial Distribution
GS185907996096165 [Unit of Use]

FDA Product Code

FMINeedle, Hypodermic, Single Lumen

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-03
Device Publish Date2020-01-24

On-Brand Devices [MICRON, droplet pen needle]

05907996096169Sterile, single use MICRON, droplet pen needles, intended to be used with a pen injector device
05907996096152Sterile, single use MICRON, droplet pen needles, intended to be used with a pen injector device

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