Identity
- Trade Name
- TKMD FDA UDI
- Generic Name
- Hypodermic needle, single-use FDA UDI
- Device Name
- The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the needle hub. The safety sheath is simultaneously activated when manually pressed over the needle after use and prior to disposal to minimize the possibility of sharps injury. The safety sheath is activated with one-hand operation by pressing the sheath either with the finger or thumb, or by surface activation. The locking mechanism is positioned within the center and proximal end of the sheath. The hinge feature allows the medical practitioner the flexibility to adjust the sheath to its desired position for use. FDA UDI
- Model / Reference
- TKSN FDA UDI
- Description
- The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the needle hub. The safety sheath is simultaneously activated when manually pressed over the needle after use and prior to disposal to minimize the possibility of sharps injury. The safety sheath is activated with one-hand operation by pressing the sheath either with the finger or thumb, or by surface activation. The locking mechanism is positioned within the center and proximal end of the sheath. The hinge feature allows the medical practitioner the flexibility to adjust the sheath to its desired position for use. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06934841570474 FDA UDI
- 510(k) Number
- K191644 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
Yes
FDA UDI
Over-the-Counter
No
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
Category: Hypodermic needle, single-use
Tkmd by Anhui Tiankang Medical Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Hypodermic needle, single-use.
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- Yeso med — WUXI YUSHOU MEDICAL APPLIANCES CO., LTD. · Class II
- EasyTouch — MHC Medical Products · Class II
- STERiJECT TM — TSK LABORATORY, JAPAN · Class II
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Cleared under the same submission
K191644 also covers:
- MedZon Health — Anhui Tiankang Medical Technology Co., Ltd.
- MedZon Health — Anhui Tiankang Medical Technology Co., Ltd.
- TKMD — Anhui Tiankang Medical Technology Co., Ltd.
- TKMD — Anhui Tiankang Medical Technology Co., Ltd.
- TKMD — Anhui Tiankang Medical Technology Co., Ltd.
- TKMD — Anhui Tiankang Medical Technology Co., Ltd.
- TKMD — Anhui Tiankang Medical Technology Co., Ltd.
- TKMD — Anhui Tiankang Medical Technology Co., Ltd.
- TKMD — Anhui Tiankang Medical Technology Co., Ltd.
- TKMD — Anhui Tiankang Medical Technology Co., Ltd.
- TKMD — Anhui Tiankang Medical Technology Co., Ltd.
- TKMD — Anhui Tiankang Medical Technology Co., Ltd.
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 |
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Manufacturer
- Manufacturer
- Anhui Tiankang Medical Technology Co., Ltd.
Sources (1)
- FDA UDI 13cce607-ca1b-4961-ac2f-189f78ab9de5 34 fields · synced Jun 8, 2026