Identity
- Trade Name
- Alpha™ Press Needles FDA UDI
- Generic Name
- Acupuncture needle, single-use FDA UDI
- Device Name
- Needles are individually packaged in sterile, tamper-evident blister packs with a plastic case and sheath to prevent contact with the needle and tape. FDA UDI
- Model / Reference
- 0.25 x 2.0 mm FDA UDI
- Description
- Needles are individually packaged in sterile, tamper-evident blister packs with a plastic case and sheath to prevent contact with the needle and tape. FDA UDI
Identifiers
- Catalog Number
- NP1-25 FDA UDI
- Primary DI / UDI-DI
- 00818318028049 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
No
FDA UDI
Category: Acupuncture needle, single-use
Alpha™ Press Needles by Prime Holly 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
- Prime Holly Corporation
Sources (1)
- FDA UDI 3c0fb58d-a900-4744-9303-a4f7e9b374ce 36 fields · synced May 29, 2026