Identity
- Trade Name
- DBC Detox 5 FDA UDI
- Generic Name
- Acupuncture needle, single-use FDA UDI
- Device Name
- DBC Detox 5 is new sterile, DBC needle 13mm in length with a highly visible plastic orange handle. Suitable for general and facial acupuncture, this needle is also great for those using the NADA protocol. The bright orange 25mm handle makes this needle easy to locate during removal or if dropped on the floor. Manufactured in an automated facility, this needle features consistency and quality unrivaled by other needles in the market. Box of 500 needles (100 packs of 5 needles). FDA UDI
- Model / Reference
- dtx.22x13 FDA UDI
- Description
- DBC Detox 5 is new sterile, DBC needle 13mm in length with a highly visible plastic orange handle. Suitable for general and facial acupuncture, this needle is also great for those using the NADA protocol. The bright orange 25mm handle makes this needle easy to locate during removal or if dropped on the floor. Manufactured in an automated facility, this needle features consistency and quality unrivaled by other needles in the market. Box of 500 needles (100 packs of 5 needles). FDA UDI
Identifiers
- Catalog Number
- dtx.22x13 FDA UDI
- Primary DI / UDI-DI
- 18800018900854 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
DBC Detox 5 by Dong Bang Medical co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Dong Bang Medical co., Ltd.
Sources (1)
- FDA UDI 5b8b607a-afb6-43af-8a36-75435e65b49c 37 fields · synced Jun 1, 2026