STERiJECT TM

GUDID 14571225315871

TSK STERiJECT Premium Disposable Hypodermic Needle

TSK LABORATORY, JAPAN

Hypodermic needle, single-use
Primary Device ID14571225315871
NIH Device Record Keyf04bb5a5-0314-40ee-ae3d-e1a14636856a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTERiJECT TM
Version Model NumberPRE-32013
Company DUNS716217877
Company NameTSK LABORATORY, JAPAN
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Dimensions

Outer Diameter0.23 Millimeter
Outer Diameter0.23 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS104571225315843 [Unit of Use]
GS104571225315874 [Primary]
GS114571225315871 [Package]
Contains: 04571225315874
Package: Carton [60 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 StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-10-23
Device Publish Date2016-09-17

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