Image Control Box

GUDID 00850007069445

Image Control Box (ICB-4K)

VISEON, INC.

General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope
Primary Device ID00850007069445
NIH Device Record Key30ace6d8-3c51-40d0-9763-0ae584ac2631
Commercial Distribution StatusIn Commercial Distribution
Brand NameImage Control Box
Version Model NumberICB-4K
Company DUNS096680671
Company NameVISEON, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850007069445 [Primary]

FDA Product Code

FSOMicroscope, Surgical, General & Plastic Surgery

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-13
Device Publish Date2024-02-05

Devices Manufactured by VISEON, INC.

00850007069650 - MISScope 4K2024-02-14 MISScope 4K, 18 Dia, 50L
00850007069346 - MaxView System - Lateral Set2024-02-13 MaxView System - Lateral Set Gen 2, Short
00850007069353 - MaxView System - Lateral Set2024-02-13 MaxView System - Lateral Set Gen 2, Long
00850007069360 - Imager Adaptor for NuVasive® MaXcess® 4 Retractor2024-02-13 Imager Adaptor for NuVasive® MaXcess® 4 Retractor, 5 -pk Carton
00850007069377 - Imager Adaptor for Globus Mars™3VL Retractor2024-02-13 Imager Adaptor for Globus Mars™3VL Retractor, 5-pk Carton
00850007069391 - Imager Adaptor for Alphatec PTP™ Retractor2024-02-13 Imager Adaptor for Alphatec PTP™ Retractor, 5-pk Carton
00850007069445 - Image Control Box2024-02-13Image Control Box (ICB-4K)
00850007069445 - Image Control Box2024-02-13 Image Control Box (ICB-4K)
00850007069438 - Imager Adaptor for Stryker Niagra® Retractor2024-02-13 Imager Adaptor for Stryker Niagra® Retractor, 5-pk Carton

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