Identity
- Trade Name
- Expert FDA UDI
- Generic Name
- Acupuncture needle, single-use FDA UDI
- Device Name
- 0.20x50mm acupuncture needles (10 needles with one tube per pack, 1000 per box). FDA UDI
- Model / Reference
- EP10-2050 FDA UDI
- Description
- 0.20x50mm acupuncture needles (10 needles with one tube per pack, 1000 per box). FDA UDI
Identifiers
- Catalog Number
- NA-EP10-2050 FDA UDI
- Primary DI / UDI-DI
- 00807689100546 FDA UDI
- 510(k) Number
- K970574 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
Dimensions & Sizes
- Size
- Length — 2.0 Inch FDA UDINeedle Gauge — 36 Gauge FDA UDI
Category: Acupuncture needle, single-use
Expert by C A I Industries Corp — 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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- SHUNLI — Wuxi Jiajian Medical Instrument Co., Ltd. · Class II
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- Millennia Bulk Acupuncture Needle — UPC MEDICAL SUPPLIES, INC. · Class II
Cleared under the same submission
K970574 also covers:
- Expert — C A I INDUSTRIES CORP
- Expert — C A I INDUSTRIES CORP
- Expert — C A I INDUSTRIES CORP
- Expert — C A I INDUSTRIES CORP
- Expert — C A I INDUSTRIES CORP
- Expert — C A I INDUSTRIES CORP
- Expert — C A I INDUSTRIES CORP
- Expert — C A I INDUSTRIES CORP
- Expert — C A I INDUSTRIES CORP
- Expert — C A I INDUSTRIES CORP
- Expert — C A I INDUSTRIES CORP
- Expert — C A I INDUSTRIES CORP
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- C A I Industries Corp
Sources (1)
- FDA UDI 6dde764d-abc8-4668-9d2d-f22d8ad7839e 36 fields · synced May 30, 2026