Identity
- Trade Name
- BON Spring Needles FDA UDI
- Generic Name
- Acupuncture needle, single-use FDA UDI
- Device Name
- STERILE ACUPUNCTURE NEEDLES FOR SINGLE USE are manufactured from stainless steel .Ten needles with one tube per sterile, individually blister package, 1000 needles per box FDA UDI
- Model / Reference
- 0.30*30mm FDA UDI
- Description
- STERILE ACUPUNCTURE NEEDLES FOR SINGLE USE are manufactured from stainless steel .Ten needles with one tube per sterile, individually blister package, 1000 needles per box FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06977427142894 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
BON Spring Needles 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.
- 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.
- 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 7db083e1-34b3-46ff-9a9c-c04c1543e37f 34 fields · synced May 30, 2026