STERiJECT TM

GUDID 24571225317346

TSK STERiJECT Premium Disposable Hypodermic Needle

TSK LABORATORY, JAPAN

Hypodermic needle, single-use

Primary Device ID	24571225317346
NIH Device Record Key	fef4d132-65ec-43e9-9e66-0836149d86c1
Commercial Distribution Status	In Commercial Distribution
Brand Name	STERiJECT TM
Version Model Number	HPC-29013E
Company DUNS	716217877
Company Name	TSK LABORATORY, JAPAN
Device Count	320
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	true

Device Dimensions

Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter
Outer Diameter	0.33 Millimeter
Length	13 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04571225317243 [Unit of Use]
GS1	04571225317342 [Primary]
GS1	14571225317349 [Package] Contains: 04571225317342 Package: [10 Units] In Commercial Distribution
GS1	24571225317346 [Package] Contains: 14571225317349 Package: [2 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K970370

FDA Product Code

FMI	Needle, hypodermic, single lumen

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2020-12-15
Device Publish Date	2020-05-22

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