Identity
- Trade Name
- Curved Tip Needle FDA UDI
- Generic Name
- Peripheral nerve-block blunt needle FDA UDI
- Device Name
- 25G x 2 1/2"(63mm) Clear plastic hub FDA UDI
- Model / Reference
- SBB63-25 FDA UDI
- Description
- 25G x 2 1/2"(63mm) Clear plastic hub FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04526737170374 FDA UDI
- 510(k) Number
- K961151 FDA UDI
- FDA Product Code
- BSP FDA UDI
- GMDN Term
- Peripheral nerve-block blunt needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5150 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
No
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 25 Gauge FDA UDILength — 63 Millimeter FDA UDI
Category: Peripheral nerve-block blunt needle
Curved Tip Needle by Hakko Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Peripheral nerve-block blunt needle.
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- Stimuplex® — B. BRAUN MEDICAL INC. · Class II
Cleared under the same submission
K961151 also covers:
- Chiba-Type Spinal Needle — HAKKO CO., LTD.
- Chiba-Type Spinal Needle — HAKKO CO., LTD.
- Chiba-Type Spinal Needle — HAKKO CO., LTD.
- Chiba-Type Spinal Needle — HAKKO CO., LTD.
- Chiba-Type Spinal Needle — HAKKO CO., LTD.
- Chiba-Type Spinal Needle — HAKKO CO., LTD.
- Chiba-Type Spinal Needle — HAKKO CO., LTD.
- Chiba-Type Spinal Needle — HAKKO CO., LTD.
- Chiba-Type Spinal Needle — HAKKO CO., LTD.
- Curved Tip Needle — HAKKO CO., LTD.
- Curved Tip Needle — HAKKO CO., LTD.
- Nerve Block Needle — HAKKO 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
- Hakko Co., Ltd.
Sources (1)
- FDA UDI 7abbd345-a66c-4ede-ba34-cbd12bf3daee 36 fields · synced May 30, 2026