FDA.reportPublic FDA data

Olympus

Primary DI
00821925046290
Brand
Olympus
Company
Gyrus ACMI, LLC
Model
ISM-1200382
Device description
Digital Hub, nCare 4K, MD
Published
2025-04-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FTALight, Surgical, Accessories
LMBDevice, Digital Image Storage, Radiological
LMDSystem, Digital Image Communications, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTALight, Surgical, AccessoriesGeneral, Plastic Surgery2
LMBDevice, Digital Image Storage, RadiologicalRadiology1
LMDSystem, Digital Image Communications, RadiologicalRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925046290PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925046290008219250462908219250462900821925046290

GMDN Terms#

Term, Definition table
TermDefinition
Operating room equipment remote controlA hand-operated electronic unit with a configuration of analogue or digital push-buttons (alphanumeric, colour-, or symbol-coded) designed to control the functions of an operating table (e.g., orthopaedic operating table, ophthalmic operating table), lights, and/or cameras in the operating room (OR) from a distance via a connected cable or wirelessly [e.g., radio-frequency (RF), infrared (IR) transmission]. It is intended to be operated by the healthcare provider.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
007198742
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00821925014206Gyrus ACMI1404202015-10-24
00821925014213Gyrus ACMI1404212015-10-24
00821925014237Gyrus ACMI1404232015-10-24
00821925014244Gyrus ACMI1404252015-10-24
00821925014251Gyrus ACMI1404262015-10-24
00821925014268Gyrus ACMI1404272015-10-24
00821925014299Gyrus ACMI1404342015-10-24
00821925014558Gyrus ACMI1403402015-10-24
00821925014565Gyrus ACMI1403412015-10-24
00821925014572Gyrus ACMI1404102015-10-24
00821925014589Gyrus ACMI1404112015-10-24
00821925014596Gyrus ACMI1404122015-10-24
00821925014619Gyrus ACMI1404152015-10-24
00821925014626Gyrus ACMI1404162015-10-24
00821925014640Gyrus ACMI1404182015-10-24
00821925014916Gyrus ACMI1403302015-10-24
00821925015210Gyrus ACMI1403312015-10-24
00821925015227Gyrus ACMI1403322015-10-24
00821925015234Gyrus ACMI1403332015-10-24
00821925015241Gyrus ACMI1403342015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00854810007229iCRco Clarity ViewerIcRco, Inc.LMB2026-07-22
04056481147099Buzz O.R. ComputeBrainlab SELMD2026-07-09
00850054590169interWORKSAvreo IncLMD2026-07-08
00850631008872Roentgen WorksBrit Systems, LLCLMB2026-06-23
00850025268417Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LMD2026-06-05
00850631008865Roentgen WorksBrit Systems, LLCLMB2026-06-05
30009336010630Nissha Medical TechnologiesGRAPHIC CONTROLS ACQUISITION CORPLMD2026-06-01
04995047074816CuratOREIZO CORPORATIONLMB2026-05-29
08800026700890Medit AuraVueMedit Corp.LMD2026-05-11
00628105001212Vitrea ReadCanon Medical Informatics A/SLMD2026-04-27
00745426000028MiPACS Storage ServerApryse Software Corp.LMB2026-04-27
16931918170732InvenioGRI Medical & Electronic Technology Co., Ltd.FTA2026-04-17
00628105001229Vitrea ReadCanon Medical Informatics A/SLMD2026-04-03
10748426144560Medline-MicrotekMicrotek Medical LLCFTA2026-02-18
00748426142934Skytron®Microtek Medical LLCFTA2026-02-05
00748426145027NAMicrotek Medical LLCFTA2026-02-05
20748426262704Medline-MicrotekMicrotek Medical LLCFTA2026-01-05
00628105001205Vitrea ReadCanon Medical Informatics A/SLMD2025-11-21
80080196761844MEDLINEMEDLINE INDUSTRIES, INC.FTA2025-11-04
00612479273580McKessonMCKESSON MEDICAL-SURGICAL INC.LMD2025-07-15
00612479274174McKessonMCKESSON MEDICAL-SURGICAL INC.LMD2025-07-15
00612479274198McKessonMCKESSON MEDICAL-SURGICAL INC.LMD2025-07-15
10724995245457HexaLuxSTERIS CORPORATIONFTA2025-05-05
00300021174552Lilly TogetherELI LILLY AND COMPANYLMD2024-02-16
00300021175559Lilly TogetherELI LILLY AND COMPANYLMD2024-02-16
20885380184113CARDINAL HEALTHCardinal Health 200, LLCFTA2023-12-28
20885380184120CARDINAL HEALTHCardinal Health 200, LLCFTA2023-12-28
20885380184137CARDINAL HEALTHCardinal Health 200, LLCFTA2023-12-28
50885380184787CARDINAL HEALTHCardinal Health 200, LLCFTA2023-12-28
00724995203399NASTERIS CORPORATIONFTA2023-11-17