Identity
- Trade Name
- STERiJECT TM FDA UDI
- Generic Name
- Hypodermic needle, single-use FDA UDI
- Device Name
- TSK STERiJECT Premium Disposable Hypodermic Needle FDA UDI
- Model / Reference
- LDS-27006I FDA UDI
- Description
- TSK STERiJECT Premium Disposable Hypodermic Needle FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04580708067445 FDA UDI
- 510(k) Number
- K970370 FDA UDI
- FDA Product Code
- FMI FDA UDI
- GMDN Term
- Hypodermic needle, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
- Outer Diameter — 0.4 Millimeter FDA UDILength — 6 Millimeter FDA UDI
Category: Hypodermic needle, single-use
STERiJECT TM by Tsk Laboratory, Japan — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hypodermic needle, single-use.
- Monoject — Cardinalhealth · Class II
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- Safety Needle — Jiangsu Micsafe Medical Technology Co., Ltd · Class IIa
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- 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
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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 (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 (1)
- FDA UDI 5b74b1f2-fda9-47b0-a51f-643e477e5702 35 fields · synced Jun 6, 2026