Identity
- Trade Name
- TCMzoneHuaTuo FDA UDI
- Generic Name
- Acupuncture needle, single-use FDA UDI
- Device Name
- T1K Type Acupuncture Needle, 0.35mm x 40mm, Spring Handle, Guide Tube, 10 needles/blister, 1000 needles/box FDA UDI
- Model / Reference
- T1K Type 0.35mm x 40mm FDA UDI
- Description
- T1K Type Acupuncture Needle, 0.35mm x 40mm, Spring Handle, Guide Tube, 10 needles/blister, 1000 needles/box FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810202812161 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
Yes
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
TCMzoneHuaTuo by TCMZone, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- TCMZone, LLC
Sources (1)
- FDA UDI c1d30c85-b4a2-4ef7-8bd4-50558966f8c1 33 fields · synced Jun 6, 2026