Identity
- Trade Name
- STERILE ACUPUNCTURE NEEDLES FOR SINGLE USE FDA UDI
- Generic Name
- Acupuncture needle, single-use FDA UDI
- Device Name
- The AIK Sterile Acupuncture Needles are manufactured from stainless steel and sterilized with ethylene oxide gas. One needle with one tube per sterile, individually blister package, 100 needles per box. FDA UDI
- Model / Reference
- 0.22*15 FDA UDI
- Description
- The AIK Sterile Acupuncture Needles are manufactured from stainless steel and sterilized with ethylene oxide gas. One needle with one tube per sterile, individually blister package, 100 needles per box. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971685270177 FDA UDI
- 510(k) Number
- K162566 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
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
Sterile Acupuncture Needles For Single Use by Changchun AIK Medical Devices Co., 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
K162566 also covers:
- BON Spring Needles — Changchun AIK Medical Devices Co., Ltd.
- BON Spring Needles — Changchun AIK Medical Devices Co., Ltd.
- BON Spring Needles — Changchun AIK Medical Devices Co., Ltd.
- KMA — Changchun AIK Medical Devices Co., Ltd.
- STERILE ACUPUNCTURE NEEDLES FOR SINGLE USE — Changchun AIK Medical Devices Co., Ltd.
- STERILE ACUPUNCTURE NEEDLES FOR SINGLE USE — Changchun AIK Medical Devices Co., Ltd.
- STERILE ACUPUNCTURE NEEDLES FOR SINGLE USE — Changchun AIK Medical Devices Co., Ltd.
- STERILE ACUPUNCTURE NEEDLES FOR SINGLE USE — Changchun AIK Medical Devices Co., Ltd.
- STERILE ACUPUNCTURE NEEDLES FOR SINGLE USE — Changchun AIK Medical Devices Co., Ltd.
- STERILE ACUPUNCTURE NEEDLES FOR SINGLE USE — Changchun AIK Medical Devices Co., Ltd.
- STERILE ACUPUNCTURE NEEDLES FOR SINGLE USE — Changchun AIK Medical Devices Co., Ltd.
- STERILE ACUPUNCTURE NEEDLES FOR SINGLE USE — Changchun AIK Medical Devices Co., 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 |
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Manufacturer
- Manufacturer
- Changchun AIK Medical Devices Co., Ltd.
Sources (1)
- FDA UDI 4ba45319-0487-4046-a29f-a448e8d49cb3 34 fields · synced May 30, 2026