← Back to catalogue

C-View® Pro System

FDA UDI

Class II (US FDA UDI)

by Carrot Medical, Llc

Identity

Trade Name
C-View® Pro System FDA UDI
Generic Name
Image display unit, colour FDA UDI
Device Name
The C-View® Pro System enables the interventional suite to utilize video integration from multiple modality inputs. FDA UDI
Model / Reference
100300 FDA UDI
Description
The C-View® Pro System enables the interventional suite to utilize video integration from multiple modality inputs. FDA UDI

Identifiers

Catalog Number
100300 FDA UDI
Primary DI / UDI-DI
00859589006022 FDA UDI
510(k) Number
K083321 FDA UDI
FDA Product Code
DXJ FDA UDI
GMDN Term
Image display unit, colour FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2450 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

Category: Image display unit, colour

C-View® Pro System by Carrot Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Image display unit, colour.

Cleared under the same submission

K083321 also covers:

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
Carrot Medical, Llc

Sources (1)

  • FDA UDI 11321891-4298-42cb-92d5-7af0d2befcb9 36 fields · synced May 30, 2026