Identity
- Trade Name
- SEIRIN SPINEX NEEDLE FDA UDI
- Generic Name
- Acupuncture needle, single-use FDA UDI
- Device Name
- An essential part of cosmetic acupuncture and other treatment modalities, Spinex™ intradermal needles (hinai-shin) provide you with a high quality option for specialized acupuncture treatments. These individually packaged, disposable needles are made entirely of surgical stainless steel. The heat-sealed blister package ensures sterility, while the perforated tear-off strip makes them easy to use. With a ring handle measuring 1.5mm in diameter, Spinex™ is available in 3 different lengths. To use, simply open the blister package, grip the head of the needle with tweezers, remove and insert. One sterile needle per blister package. Box of 100 needles. FDA UDI
- Model / Reference
- NS No.02(0.12)x4mm FDA UDI
- Description
- An essential part of cosmetic acupuncture and other treatment modalities, Spinex™ intradermal needles (hinai-shin) provide you with a high quality option for specialized acupuncture treatments. These individually packaged, disposable needles are made entirely of surgical stainless steel. The heat-sealed blister package ensures sterility, while the perforated tear-off strip makes them easy to use. With a ring handle measuring 1.5mm in diameter, Spinex™ is available in 3 different lengths. To use, simply open the blister package, grip the head of the needle with tweezers, remove and insert. One sterile needle per blister package. Box of 100 needles. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547248500023 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
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
- Outer Diameter — 0.12 Millimeter FDA UDILength — 4 Millimeter FDA UDI
Category: Acupuncture needle, single-use
Seirin Spinex Needle by Seirin Corporation — 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
- Seirin Corporation
Sources (1)
- FDA UDI 57f34050-a760-41f8-8f04-aadbc69c33d6 35 fields · synced Jun 8, 2026