Identity
- Trade Name
- SEIRIN ACUPUNCTURE NEEDLE FDA UDI
- Generic Name
- Acupuncture needle, single-use FDA UDI
- Device Name
- Metal Handle with Guide Tube FDA UDI
- Model / Reference
- KB-Type No.10(0.35)x150mm FDA UDI
- Description
- Metal Handle with Guide Tube FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547248240646 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
- Not 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
Yes
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 — 150 Millimeter FDA UDIOuter Diameter — 0.35 Millimeter FDA UDI
Seirin Acupuncture Needle by Seirin Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Seirin Corporation
Sources (1)
- FDA UDI 62d58adc-fc44-4b68-9fb2-c2c3a4e1d85a 36 fields · synced May 31, 2026