DEVICE: STERiJECT TM (04571225314471)

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Device Record History
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Device Identifier (DI) Information
STERiJECT TM
PRC-25050ISG
In Commercial Distribution

TSK LABORATORY, JAPAN
04571225314471
GS1

1
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© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
59230 Hypodermic needle, single-use
A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.
Active false
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FDA Product Code

[?]
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
No CLOSE

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Length: 50 Millimeter
Outer Diameter: 0.5 Millimeter
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Device Record Status
cb860b48-5dd9-4ccc-9da1-79d4ecd569c3
October 23, 2019
5
December 23, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
04571225314358 40 04571225314471 In Commercial Distribution Box
14571225314355 75 04571225314358 In Commercial Distribution Carton
14571225314478 20 04571225314471 In Commercial Distribution Carton
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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: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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