← Back to catalogue

Pixa

FDA UDI

Class II (US FDA UDI)

by Santa Barbara Imaging Systems, Inc.

Identity

Trade Name
Pixa FDA UDI
Generic Name
Rigid optical arthroscope, single-use FDA UDI
Device Name
Camera, Single Use, 4mm, 30 Deg, EXT Length, Universal FDA UDI
Model / Reference
85-10-6431-U FDA UDI
Description
Camera, Single Use, 4mm, 30 Deg, EXT Length, Universal FDA UDI

Identifiers

Catalog Number
85-10-6431-U FDA UDI
Primary DI / UDI-DI
00812231033616 FDA UDI
FDA Product Code
GCJ FDA UDI
GMDN Term
Rigid optical arthroscope, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 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
MRI Safety
MR Unsafe FDA UDI

Category: Rigid optical arthroscope, single-use

Pixa by Santa Barbara Imaging Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rigid optical arthroscope, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Santa Barbara Imaging Systems, Inc.

Sources (1)

  • FDA UDI 314da12e-cee2-48de-9723-d1d1776908ed 34 fields · synced May 30, 2026