Identity
- Trade Name
- DBC Spring Single FDA UDI
- Generic Name
- Acupuncture needle, single-use FDA UDI
- Device Name
- DBC Spring Singles Acupuncture Needles are sterile disposable, surgical stainless steel Korean acupuncture needles with "spring" style metal handle. The 15 mm length needle features a 20 mm handle while all other lengths feature a 25 mm 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
- dST.20x15 FDA UDI
- Description
- DBC Spring Singles Acupuncture Needles are sterile disposable, surgical stainless steel Korean acupuncture needles with "spring" style metal handle. The 15 mm length needle features a 20 mm handle while all other lengths feature a 25 mm 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
- dST.20x15 FDA UDI
- Primary DI / UDI-DI
- 18800018900045 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 Spring 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 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 ea7165c0-b0e1-4b54-bf42-15d025ead98e 37 fields · synced May 30, 2026