SHOPKO Unifine Pentips Plus - 12mmx29G pen needles AN 3829SKO

GUDID 00761059821557

For use with injectors for the subcutaneous injection of approved drugs, including insulin

Shopko

Autoinjector needle
Primary Device ID00761059821557
NIH Device Record Keyb02bebd4-d052-4458-a797-9c2fd5de19ec
Commercial Distribution StatusIn Commercial Distribution
Brand NameSHOPKO Unifine Pentips Plus - 12mmx29G pen needles
Version Model NumberAN 3829SKO
Catalog NumberAN 3829SKO
Company DUNS023252638
Company NameShopko
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Countertrue

Customer Support Contacts

Phone920-429-2211
Emailxx@xx.xx
Phone920-429-2211
Emailxx@xx.xx

Device Dimensions

Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100761059820550 [Package]
Contains: 00761059829553
Package: Sleeve [6 Units]
In Commercial Distribution
GS100761059821557 [Package]
Contains: 00761059820550
Package: Case [24 Units]
In Commercial Distribution
GS100761059829000 [Unit of Use]
GS100761059829553 [Primary]

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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-19

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00761059821557 - SHOPKO Unifine Pentips Plus - 12mmx29G pen needles2018-07-06For use with injectors for the subcutaneous injection of approved drugs, including insulin
00761059821557 - SHOPKO Unifine Pentips Plus - 12mmx29G pen needles2018-07-06 For use with injectors for the subcutaneous injection of approved drugs, including insulin

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