Identity
- Trade Name
- AcuZone FDA UDI
- Generic Name
- Acupuncture needle, single-use FDA UDI
- Device Name
- Smooth and sharp for painless, AcuZone disposable sterile Intradermal needle are made of high quality surgical stainless steel. Steriliized with Ethylene Oxide, each needle is individually sealed. Box of 100. 0.14mm x 11mm. FDA UDI
- Model / Reference
- IN1411 FDA UDI
- Description
- Smooth and sharp for painless, AcuZone disposable sterile Intradermal needle are made of high quality surgical stainless steel. Steriliized with Ethylene Oxide, each needle is individually sealed. Box of 100. 0.14mm x 11mm. FDA UDI
Identifiers
- Catalog Number
- IN1411 FDA UDI
- Primary DI / UDI-DI
- B491IN14111 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
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
AcuZone by Wujiang City ShenLing Medical Device Co., Ltd — 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
- Wujiang City ShenLing Medical Device Co., Ltd
Sources (1)
- FDA UDI a67bb223-945a-487b-8035-218ec622a67d 35 fields · synced May 31, 2026