Identity
- Trade Name
- MP-2794-G18 FDA UDI
- Generic Name
- Needle guide, reusable FDA UDI
- Device Name
- Puncture Guide Tube FDA UDI
- Model / Reference
- MP-2794-G18 FDA UDI
- Description
- Puncture Guide Tube FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04573596210635 FDA UDI
- 510(k) Number
- K083254 FDA UDI
- FDA Product Code
- IYO FDA UDIIYN FDA UDIITX FDA UDI
- GMDN Term
- Needle guide, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1560 FDA UDI892.1550 FDA UDI892.1570 FDA UDI
- Commercial Distribution
- 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
Dimensions & Sizes
- Size
- Needle Gauge — 18 Gauge FDA UDI
Category: Needle guide, reusable
Mp-2794-G18 by FUJIFILM Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Needle guide, reusable.
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- InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Class II
- InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Class II
- Duckworth & Kent — DUCKWORTH AND KENT LIMITED · Class I
- InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Class II
- EV29L Non-Sterile Reusable PrecisionPoint Adapter — Exact Imaging · Class II
- InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Class II
Cleared under the same submission
K083254 also covers:
- MP-2794-G14 — FUJIFILM Corporation
- MP-2794-G16 — 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
- UST-981-5 — 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 |
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Manufacturer
- Manufacturer
- FUJIFILM Corporation
Sources (1)
- FDA UDI 659e957d-7dc6-4958-94d7-0a9c966230a5 36 fields · synced May 31, 2026