STERiJECT Low Dead Space, STERiJECT The Invisible Needle
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- LOW DEAD SPACE NEEDLE EUDAMEDTHE INViSIBLE NEEDLE EUDAMED
- Device Name
- TSK HYPODERMIC NEEDLE EUDAMED
- Model / Reference
- PRE-21025 EUDAMEDLDS-27006I EUDAMEDLDS-30013ICR EUDAMEDLDS-02009 EUDAMEDLDS-30013I EUDAMEDLDS-30009I EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04580708067438 EUDAMED04571225317359 EUDAMED04571225314068 EUDAMED04571225315997 EUDAMED04580708061771 EUDAMED
- Basic UDI-DI
- 4571225300011U9 EUDAMED
- 510(k) Number
- K231734 FDA 510(k)
- FDA Product Code
- QNS FDA 510(k)
- EMDN Code
- A0199 NEEDLES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5570 FDA 510(k)
- Regulation Number
- 880.5570 FDA 510(k)
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
Yes
Measuring Function
No
Incorporates Medicinal Product
No
The STERiJECT Low Dead Space and STERiJECT The Invisible Needle are single-lumen, hypodermic needles designed for injecting or aspirating fluids into or from the body. These devices are classified as Class II medical devices under FDA regulations, featuring minimal internal volume to reduce medication waste and enhance precision during procedures.
These needles are intended for use in general hospital settings and are supplied as single-use, sterile products. They comply with FDA 510(k) clearance (K231734) and EU MDR requirements, ensuring adherence to regulatory standards. Available in multiple reference codes (e.g., 3012552122, 3012478173), they are packaged for immediate clinical use and must be stored according to manufacturer guidelines to maintain sterility.
Frequently asked questions
What makes the STERiJECT needles different from standard hypodermic needles in terms of functionality?
The STERiJECT needles are designed with a low dead space feature, meaning they have minimal internal volume compared to standard hypodermic needles. This reduces medication waste during injections or aspirations, allowing for more precise dosing and better efficiency in clinical procedures.
Are the STERiJECT needles reusable, or are they meant for single-use only?
The STERiJECT needles are explicitly labeled as single-use devices. They are supplied sterile and intended for one-time use only to maintain safety and sterility standards in medical settings.
How should I store these needles to ensure they remain sterile before use?
STERiJECT needles must be stored according to the manufacturer’s guidelines to preserve sterility. Since they are packaged for immediate clinical use, they should remain in their original, unopened packaging until ready for use, away from direct sunlight, moisture, and extreme temperatures.
What regulatory pathways have these needles undergone, and where are they approved for use?
The STERiJECT needles have undergone FDA 510(k) clearance (K231734) and comply with EU MDR (Medical Device Regulation) requirements. They are classified as Class II devices under FDA regulations and are intended for use in general hospital settings as indicated by their submission category.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: STERiJECT Low Dead Space, STERiJECT The Invisible Needle, 510(k) Premarket Notification - FDA, STERiJECT™｜PRODUCT INFORMATION｜MEDICAL PRODUCTS｜TSK Laboratory, Japan, STERiJECT Low Dead Space, STERiJECT The Invisible Needle 510 (k ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K231734 | Class II | Active |
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Manufacturer
- Manufacturer
- Tsk Laboratory International Japan KK
Sources (6)
- FDA 510(k) K231734 24 fields · synced Sep 18, 2026
- EUDAMED 9e0fc8eb-ba39-46b0-9a23-1b0bcb972074 61 fields · synced Jul 9, 2026
- EUDAMED b9984550-7bef-48ee-a34c-bd5176cce0d3 61 fields · synced Jul 10, 2026
- EUDAMED 6a538bf5-3b73-4819-9739-4d3161ee60a6 61 fields · synced Jul 20, 2026
- EUDAMED 01873dd1-70b3-4956-849a-3f802925ff77 61 fields · synced Jul 21, 2026
- EUDAMED 86c4d819-6789-4701-883e-0151e2f2ca01 61 fields · synced Jul 22, 2026