Identity
- Trade Name
- SMC acupuncture needle FDA UDI
- Generic Name
- Acupuncture needle, single-use FDA UDI
- Device Name
- SMC acupuncture needle 0.25*50 (1,000pcs/Box) 25mm Handle SMC's sterile, disposable, and surgical stainless steel acupuncture needles with style handle. Due to its automated manufactering procedure, the needle provides the consistancy in its quality. FDA UDI
- Model / Reference
- 02505025 FDA UDI
- Description
- SMC acupuncture needle 0.25*50 (1,000pcs/Box) 25mm Handle SMC's sterile, disposable, and surgical stainless steel acupuncture needles with style handle. Due to its automated manufactering procedure, the needle provides the consistancy in its quality. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800020300249 FDA UDI
- 510(k) Number
- K141473 FDA UDI
- FDA Product Code
- MQX FDA UDI
- GMDN Term
- Acupuncture needle, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5580 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
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: Acupuncture needle, single-use
SMC acupuncture needle by SMC Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Acupuncture needle, single-use.
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Cleared under the same submission
K141473 also covers:
- SMC acupuncture needle — SMC Ltd.
- SMC acupuncture needle — SMC Ltd.
- SMC acupuncture needle — SMC Ltd.
- SMC acupuncture needle — SMC Ltd.
- SMC acupuncture needle — SMC Ltd.
- SMC acupuncture needle — SMC Ltd.
- SMC acupuncture needle — SMC Ltd.
- SMC acupuncture needle — SMC Ltd.
- SMC acupuncture needle — SMC Ltd.
- SMC acupuncture needle — SMC Ltd.
- SMC acupuncture needle — SMC Ltd.
- SMC acupuncture needle — SMC 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SMC Ltd.
Sources (1)
- FDA UDI bb6d2a77-c4a2-4c0b-af2d-ed0f2e6dd7da 35 fields · synced May 30, 2026