Identity
- Trade Name
- Gold Tai Chi™ FDA UDI
- Generic Name
- Acupuncture needle, single-use FDA UDI
- Device Name
- High quality, painless, sterile, gold plated, surgical stainless steel Chinese acupuncture needles with spiral wound gold plated copper handle. One needle with one insertion tube per sterile, individually sealed blister package. Box of 100, 0.20 x 40mm. FDA UDI
- Model / Reference
- AY8612 FDA UDI
- Description
- High quality, painless, sterile, gold plated, surgical stainless steel Chinese acupuncture needles with spiral wound gold plated copper handle. One needle with one insertion tube per sterile, individually sealed blister package. Box of 100, 0.20 x 40mm. FDA UDI
Identifiers
- Catalog Number
- AY8612 FDA UDI
- Primary DI / UDI-DI
- 16970514320523 FDA UDI
- 510(k) Number
- K023787 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
No
FDA UDI
Category: Acupuncture needle, single-use
Gold Tai Chi™ by Suzhou Shenlong Medical Apparatus Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K023787 also covers:
- Gold Tai Chi™ — Suzhou Shenlong Medical Apparatus Co., Ltd.
- Gold Tai Chi™ — Suzhou Shenlong Medical Apparatus Co., Ltd.
- Gold Tai Chi™ — Suzhou Shenlong Medical Apparatus Co., Ltd.
- Gold Tai Chi™ — Suzhou Shenlong Medical Apparatus Co., Ltd.
- Gold Tai Chi™ — Suzhou Shenlong Medical Apparatus Co., Ltd.
- Gold Tai Chi™ — Suzhou Shenlong Medical Apparatus Co., Ltd.
- Gold Tai Chi™ — Suzhou Shenlong Medical Apparatus Co., Ltd.
- Gold Tai Chi™ — Suzhou Shenlong Medical Apparatus Co., Ltd.
- Gold Tai Chi™ — Suzhou Shenlong Medical Apparatus Co., Ltd.
- Master Tai Chi™ — Suzhou Shenlong Medical Apparatus Co., Ltd.
- Master Tai Chi™ — Suzhou Shenlong Medical Apparatus Co., Ltd.
- Master Tai Chi™ — Suzhou Shenlong Medical Apparatus 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
- Suzhou Shenlong Medical Apparatus Co., Ltd.
Sources (1)
- FDA UDI b5b58086-2f53-4df8-8a72-c1407ed03247 37 fields · synced May 30, 2026