FDA.reportPublic FDA data

Olympus

Primary DI
00821925046276
Brand
Olympus
Company
Gyrus ACMI, LLC
Model
ISM-1200364
Device description
Medical Video Recorder Digital Hub, nCare 4K
Published
2025-04-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
00821925046276PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925046276008219250462768219250462760821925046276

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
00821925034013Expandacell708907302018-09-13
00821925034020Gyrus ACMI708909072018-09-13
00821925034037Gyrus ACMI708909082018-09-13
00821925034532Gyrus ACMI8909112018-09-13
00821925037069Rhino Rocket708907292018-09-13
00821925037076Rhino Rocket708907312018-09-13
00821925037090Gyrus ACMI708907332018-09-13
00821925037106SlimLine708907342018-09-13
00821925037113Gyrus ACMI708907352018-09-13
00821925037120Gyrus ACMI708907372018-09-13
00821925037137Gyrus ACMI708907382018-09-13
00821925037144Gyrus ACMI708907392018-09-13
00821925037151Gyrus ACMI708907402018-09-13
00821925037168Gyrus ACMI708907412018-09-13
00821925037175Gyrus ACMI708907422018-09-13
00821925037182Gyrus ACMI708907432018-09-13
00821925037199Gyrus ACMI708907502018-09-13
00821925037205Gyrus ACMI708907512018-09-13
00821925037212Gyrus ACMI708907522018-09-13
00821925037229Gyrus ACMI708907532018-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10197344006915MedlineMEDLINE INDUSTRIES, INC.FTA2023-11-05
50885380183001CARDINAL HEALTHCardinal Health 200, LLCFTA2023-08-11
50885380182998CARDINAL HEALTHCardinal Health 200, LLCFTA2023-08-11
16931918117362AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2023-07-20