Identity
- Trade Name
- DBC Pipe Ten FDA UDI
- Generic Name
- Acupuncture needle, single-use FDA UDI
- Device Name
- DBC Pipe Ten Acupuncture Needles are sterile disposable, surgical stainless steel acupuncture needles with 25 mm "pipe" style metal handle. 10 needles with 1 insertion tube per sterile bulk package. Box of 1000 needles. FDA UDI
- Model / Reference
- dPB.20x15 FDA UDI
- Description
- DBC Pipe Ten Acupuncture Needles are sterile disposable, surgical stainless steel acupuncture needles with 25 mm "pipe" style metal handle. 10 needles with 1 insertion tube per sterile bulk package. Box of 1000 needles. FDA UDI
Identifiers
- Catalog Number
- dPB.20x15 FDA UDI
- Primary DI / UDI-DI
- 18800018900564 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 Pipe Ten 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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- SHUNLI — Wuxi Jiajian Medical Instrument Co., Ltd. · Class II
- AcuZone — Wujiang City ShenLing Medical Device Co., Ltd · Class II
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- Millennia Bulk Acupuncture Needle — UPC MEDICAL SUPPLIES, INC. · Class II
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 91990aa5-d8e6-4fba-9f24-3ad070315717 37 fields · synced Jun 1, 2026