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STERiJECT TM
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref PRC-22050IModel PRE-21025Ref HPC-27013ARef PRE-30006IRef PRC-27025IRef PRE-30006Ref PRE-30004Ref PRC-19038IRef HPC-31013ERef HPC-30013ARef HPC-29013ERef HPC-27013IRef PRE-32009Ref PRE-23019Ref HPC-27019IRef PRE-33013Ref PRE-30004IRef PRC-27013I
Identity
- Trade Name
- STERiJECT EUDAMEDSTERiJECT TM FDA UDI
- Generic Name
- Hypodermic needle, single-use FDA UDI
- Device Name
- TSK HYPODERMIC NEEDLE EUDAMEDTSK STERiJECT Premium Disposable Hypodermic Needle FDA UDI
- Model / Reference
- PRE-32009 EUDAMEDFDA UDIPRE-21025 EUDAMEDPRC-22050I EUDAMEDHPC-27013A EUDAMEDPRE-30006I EUDAMEDPRC-27025I EUDAMEDPRE-30006 EUDAMEDPRE-30004 EUDAMEDPRC-19038I EUDAMEDHPC-31013E EUDAMEDHPC-30013A EUDAMEDHPC-29013E EUDAMEDHPC-27013I EUDAMEDPRE-23019 EUDAMEDHPC-27019I EUDAMEDPRE-33013 EUDAMEDPRE-30004I EUDAMEDPRC-27013I EUDAMED
- Description
- TSK STERiJECT Premium Disposable Hypodermic Needle FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04571225313399 EUDAMED04571225310718 EUDAMED04571225315560 EUDAMED04571225315102 EUDAMED04571225315539 EUDAMED04571225315485 EUDAMED04571225316727 EUDAMED04571225317618 EUDAMED04571225310725 EUDAMED04571225317243 EUDAMED04571225314150 EUDAMED04571225315799 EUDAMED04580708065991 EUDAMED04571225314037 EUDAMED04571225315966 EUDAMED04580708065977 EUDAMED04571225315515 EUDAMED04571225315065 EUDAMED04571225315812 FDA UDI
- Basic UDI-DI
- 4571225300011U9 EUDAMED
- 510(k) Number
- K970370 FDA UDI
- FDA Product Code
- FMI FDA UDI
- EMDN Code
- A0199 NEEDLES - OTHER EUDAMED
- GMDN Term
- Hypodermic needle, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5570 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 9 Millimeter FDA UDIOuter Diameter — 0.23 Millimeter FDA UDI
Category: Hypodermic needle, single-use
STERiJECT TM by Tsk Laboratory, Japan — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Hypodermic needle, single-use.
- Monoject — Cardinalhealth · Class II
- Pinpoint GT — Bard Access Systems, Inc. · Class II
- Safety Needle — Jiangsu Micsafe Medical Technology Co., Ltd · Class IIa
- Syringe w/Needle, Non-Toxic, 25G x 1", Luer Lock — Dynarex Corp. · Class II
- Yeso med — WUXI YUSHOU MEDICAL APPLIANCES CO., LTD. · Class II
- EasyTouch — MHC Medical Products · Class II
- Comfort EZ Pro — S.D.I. USA, INC. · Class II
- Jelco — ICU MEDICAL, INC. · Class II
Cleared under the same submission
K970370 also covers:
- STERiJECT TM — TSK LABORATORY, JAPAN
- STERiJECT TM — TSK LABORATORY, JAPAN
- STERiJECT TM — TSK LABORATORY, JAPAN
- STERiJECT TM — TSK LABORATORY, JAPAN
- STERiJECT TM — TSK LABORATORY, JAPAN
- STERiJECT TM — TSK LABORATORY, JAPAN
- STERiJECT TM — TSK LABORATORY, JAPAN
- STERiJECT TM — TSK LABORATORY, JAPAN
- STERiJECT TM — TSK LABORATORY, JAPAN
- STERiJECT TM — TSK LABORATORY, JAPAN
- STERiJECT TM — TSK LABORATORY, JAPAN
- STERiJECT TM — TSK LABORATORY, JAPAN
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tsk Laboratory, Japan
Sources (19)
- FDA UDI 8ff6b127-904d-4d75-ace2-10078b0cdf39 35 fields · synced Aug 4, 2026
- EUDAMED 94d7453f-718e-4887-a43d-5ef0d7aad1b0 61 fields · synced Jul 8, 2026
- EUDAMED 5bd5dcb9-7607-430e-9d64-6a766d2d0ce2 61 fields · synced Jul 8, 2026
- EUDAMED 315f1859-8bef-40d7-ab98-9bb1b5626639 61 fields · synced Jul 9, 2026
- EUDAMED cc1923a0-b0d8-4565-9723-cbb5fe0ff74d 61 fields · synced Jul 9, 2026
- EUDAMED 7749b9cd-b6f6-42ae-8703-7db07c22a192 61 fields · synced Jul 9, 2026
- EUDAMED 9de33704-173f-4935-82c4-4819bdf37404 61 fields · synced Jul 13, 2026
- EUDAMED 06403621-7427-4314-bf93-b193b9e8ba81 61 fields · synced Jul 14, 2026
- EUDAMED 29067f4d-7811-4df1-b22b-d35184128e0b 61 fields · synced Jul 17, 2026
- EUDAMED 5fe8b0f1-fd50-4bae-a9c5-346a725f9442 61 fields · synced Jul 19, 2026
- EUDAMED 4f53f958-7d19-450f-a7ca-646bbf487c37 61 fields · synced Jul 19, 2026
- EUDAMED 8ea1282b-67f5-454a-bcb3-a32d5f413d15 61 fields · synced Jul 20, 2026
- EUDAMED 2ee6b217-571f-4c88-9b57-43a786d85746 61 fields · synced Jul 20, 2026
- EUDAMED 017cb8a8-3c75-43e8-8361-d072aa0f1072 61 fields · synced Jul 26, 2026
- EUDAMED 69cc9061-303c-4f2a-b2a0-f69e0a6a1334 61 fields · synced Aug 2, 2026
- EUDAMED 67c729b5-4631-4d7d-bb7e-513d2518ff31 61 fields · synced Aug 3, 2026
- EUDAMED b5577bd8-3f4c-4b2b-abcb-7b8a19312201 61 fields · synced Aug 3, 2026
- EUDAMED 064c1d17-e2fc-46c1-b53d-07cf40d1fbbc 61 fields · synced Aug 4, 2026
- EUDAMED 75a0bb47-3a19-4be0-a0c4-73ce5b3cc6b9 61 fields · synced Aug 4, 2026