Identity
- Trade Name
- HITACHI FDA UDI
- Generic Name
- Needle guide, reusable FDA UDI
- Device Name
- Puncture Guide Tube FDA UDI
- Model / Reference
- MP-2794-G14 FDA UDI
- Description
- Puncture Guide Tube FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04562122957359 FDA UDI
- 510(k) Number
- K083254 FDA UDI
- FDA Product Code
- OIJ FDA UDI
- GMDN Term
- Needle guide, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1560 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 14 Gauge FDA UDI
Hitachi by Hitachi, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K083254 also covers:
- MP-2794-G14 — FUJIFILM Corporation
- MP-2794-G16 — FUJIFILM Corporation
- MP-2794-G18 — FUJIFILM Corporation
- MP-2794-G20/21 — FUJIFILM Corporation
- UST-5512U-7.5 — FUJIFILM Corporation
- UST-5551 — FUJIFILM Corporation
- UST-5820-5 — FUJIFILM Corporation
- UST-9111-5 — FUJIFILM Corporation
- UST-9137 — FUJIFILM Corporation
- UST-9145 — FUJIFILM Corporation
- UST-934N-3.5 — FUJIFILM Corporation
- UST-944B-3.5 — FUJIFILM Corporation
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
- Hitachi, Ltd.
Sources (1)
- FDA UDI ef3cb070-d161-43fe-8161-0df25eb6def7 36 fields · synced May 30, 2026