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N33 CCD System

FDA UDI

Class II (US FDA UDI)

by Nical Spa

Identity

Trade Name
N33 CCD System FDA UDI
Generic Name
Fluoroscopic x-ray system video image recording unit FDA UDI
Model / Reference
N33 FDA UDI

Identifiers

Catalog Number
N331R2ZZ1 FDA UDI
Primary DI / UDI-DI
08056600520860 FDA UDI
510(k) Number
K951261 FDA UDI
FDA Product Code
JAA FDA UDI
GMDN Term
Fluoroscopic x-ray system video image recording unit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1650 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

No

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Fluoroscopic x-ray system video image recording unit

N33 CCD System by Nical Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Fluoroscopic x-ray system video image recording unit.

Cleared under the same submission

K951261 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nical Spa

Sources (1)

  • FDA UDI 07f50008-3310-49af-b7da-8acb0bf0b72b 34 fields · synced May 30, 2026