DEVICE: STERiJECT TM (04571225315324)

Device Identifier (DI) Information

STERiJECT TM
PRE-22100
In Commercial Distribution

TSK LABORATORY, JAPAN
04571225315324
GS1

100
716217877 *Terms of Use
TSK STERiJECT Premium Disposable Hypodermic Needle
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
Yes
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Hypodermic needle, single-use, sterile A sterile, sharp bevel-edged, hollow tubular metal device intended to be used in conjunction with syringes, secondary medication sets, or phlebotomy equipment (e.g., blood collection adapters or holders) to prepare and administer fluids/medications/drugs to a patient and/or to withdraw(aspirate) fluids from a patient. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
FMI Needle, hypodermic, single lumen
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K970370 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Length: 100 Millimeter
Outer Diameter: 0.7 Millimeter
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Device Record Status

73d53cb5-4301-4e42-b8e6-51e167578d13
July 06, 2018
4
September 17, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
14571225315321 60 04571225315324 In Commercial Distribution Carton
24571225315328 30 04571225315324 In Commercial Distribution
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: 04571225315317 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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