LEADER, pen needles 8471

GUDID 50096295138776

Single LEADER pen needles, intended to be used with a pen injector device for the subcutaneous injection of drugs.

HTL STREFA S A

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Primary Device ID50096295138776
NIH Device Record Keyb05a4492-797b-41df-867e-cd7961ad9bdb
Commercial Distribution StatusIn Commercial Distribution
Brand NameLEADER, pen needles
Version Model Number32G x 4 mm
Catalog Number8471
Company DUNS422528088
Company NameHTL STREFA S A
Device Count100
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100096295138771 [Primary]
GS110096295138778 [Unit of Use]
GS150096295138776 [Package]
Contains: 00096295138771
Package: Shipping box [24 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

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 Date2019-12-27
Device Publish Date2019-12-19

On-Brand Devices [LEADER, pen needles]

00096295138788Single LEADER pen needles, intended to be used with a pen injector device for the subcutaneous
50096295138776Single LEADER pen needles, intended to be used with a pen injector device for the subcutaneous i
50096295138769Single LEADER pen needles, intended to be used with a pen injector device for the subcutaneous i
50096295138752Single LEADER pen needles, intended to be used with a pen injector device for the subcutaneous i
50096295138745Single LEADER pen needles, intended to be used with a pen injector device for the subcutaneous i
50096295138738Single LEADER pen needles, intended to be used with a pen injector device for the subcutaneous i
10096295143000LEADER pen needles are sterile, single-use pen needles intended for use with pen injector device
50096295142995LEADER pen needles are sterile, single-use pen needles intended for use with pen injector device

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