DropSafe, safety pen needles 8161

GUDID 85907996098589

100 pcs sterile single use DropSafe pen needles per box, intended for use with pen injector devices for the injection of drugs.

HTL STREFA S A

Autoinjector needle
Primary Device ID85907996098589
NIH Device Record Key5ee4858f-d199-4263-b3ac-2dc07b4fa0c6
Commercial Distribution StatusIn Commercial Distribution
Brand NameDropSafe, safety pen needles
Version Model Number31G x 5mm
Catalog Number8161
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

Customer Support Contacts

Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105907996098583 [Primary]
GS115907996098580 [Package]
Contains: 05907996098583
Package: shipper box [20 Units]
In Commercial Distribution
GS185907996098589 [Unit of Use]

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 Date2021-10-26
Device Publish Date2021-10-18

On-Brand Devices [DropSafe, safety pen needles]

05907996091591100 pcs sterile single use DropSafe pen needles per box, intended to be used with a pen injector
15907996091581100 pcs sterile single use DropSafe pen needles per box, intended to be used with a pen injector
85907996098589100 pcs sterile single use DropSafe pen needles per box, intended for use with pen injector devi
159039996017963 pcs sterile single use DropSafe pen needles per bag, intended for use with pen injector device
159039996017893 pcs sterile single use DropSafe pen needles per bag, intended for use with pen injector device
859039996017713 pcs sterile single use DropSafe pen needles per bag, intended for use with pen injector device

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