Identity
- Trade Name
- Nano Tech Bulk FDA UDI
- Generic Name
- Acupuncture needle, single-use FDA UDI
- Device Name
- Nano Tech™ Bulk Five Acupuncture Needles are precisely calibrated for ease and accuracy, Nano Tech™ Bulk Five needles have been completely re-engineered for a painless acupuncture experience for you and your patient. These sterile, disposable, surgical stainless steel acupuncture needles feature an easy-to-hold, color-coded 25 mm handle. The economical bulk packaging with 5 needles and one guide tube per blister package allows for easy use with less waste. Box of 500 needles (100 packs of 5 needles with tube). FDA UDI
- Model / Reference
- Ntb.20x15 FDA UDI
- Description
- Nano Tech™ Bulk Five Acupuncture Needles are precisely calibrated for ease and accuracy, Nano Tech™ Bulk Five needles have been completely re-engineered for a painless acupuncture experience for you and your patient. These sterile, disposable, surgical stainless steel acupuncture needles feature an easy-to-hold, color-coded 25 mm handle. The economical bulk packaging with 5 needles and one guide tube per blister package allows for easy use with less waste. Box of 500 needles (100 packs of 5 needles with tube). FDA UDI
Identifiers
- Catalog Number
- Ntb.20x15 FDA UDI
- Primary DI / UDI-DI
- 18800018900670 FDA UDI
- 510(k) Number
- K990328 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
Nano Tech Bulk by Dong Bang Medical 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
K990328 also covers:
- DBC Intradermal — Dong Bang Medical co., Ltd.
- DBC Intradermal — Dong Bang Medical co., Ltd.
- DBC Intradermal — Dong Bang Medical co., Ltd.
- DBC Pipe Single — Dong Bang Medical co., Ltd.
- DBC Pipe Single — Dong Bang Medical co., Ltd.
- DBC Pipe Single — Dong Bang Medical co., Ltd.
- DBC Pipe Single — Dong Bang Medical co., Ltd.
- DBC Pipe Ten — Dong Bang Medical co., Ltd.
- DBC Pipe Ten — Dong Bang Medical co., Ltd.
- DBC Pipe Ten — Dong Bang Medical co., Ltd.
- DBC Pipe Ten — Dong Bang Medical co., Ltd.
- DBC Pipe Ten — Dong Bang Medical 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dong Bang Medical co., Ltd.
Sources (1)
- FDA UDI 8a7c13d7-3319-40de-8e60-56cbb624e8c5 37 fields · synced Jun 1, 2026