Identity
- Trade Name
- DBC Pipe Single FDA UDI
- Generic Name
- Acupuncture needle, single-use FDA UDI
- Device Name
- DBC Pipe Singles Acupuncture Needles are sterile, disposable, surgical stainless steel Korean acupuncture needles with solid 25 mm "pipe" style metal handle. One needle with one insertion tube per sterile, individually sealed blister package. Needles are secured in guide tubes with plastic holding tabs. Box of 100 needles. FDA UDI
- Model / Reference
- dPT.20x50 FDA UDI
- Description
- DBC Pipe Singles Acupuncture Needles are sterile, disposable, surgical stainless steel Korean acupuncture needles with solid 25 mm "pipe" style metal handle. One needle with one insertion tube per sterile, individually sealed blister package. Needles are secured in guide tubes with plastic holding tabs. Box of 100 needles. FDA UDI
Identifiers
- Catalog Number
- dPT.20x50 FDA UDI
- Primary DI / UDI-DI
- 18800018900533 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 Single 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 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.
- 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 0ac6880a-7131-459e-8360-9e80534a762a 37 fields · synced May 30, 2026