FDA.reportPublic FDA data

SONY

Primary DI
04548736120679
Brand
SONY
Company
SONY CORPORATION
Model
NU-MC30E
Device description
NUCLeUS OR Controller
Published
2020-09-30
Public version status
New
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTALight, Surgical, AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04548736120679PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04548736120679045487361206794548736120679

GMDN Terms#

Term, Definition table
TermDefinition
Operating room audiovisual data/device management system application softwareAn application software program, routines, and/or algorithms intended to be used in an operating room audiovisual data/device management system to enable the system to function according to its intended purpose. The software typically supports remote control of medical and non-medical devices, data management/documentation, and data communication/transfer within and outside of the operating room (OR) [e.g., teleconferencing, teaching/ telesurgery, networking with hospital systems]; it is not intended for long-term storage of patient demographics. It is typically installed into a dedicated integrated network of computers and peripherals.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690553649
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04548736183407SONYLMD-XH320T2026-04-30
04548736183414SONYLMD-XH550T2026-04-30
04548736155978SONYUP-D899MD2025-11-04
04548736155985SONYUP-X899MD2025-11-04
04548736169968SONYUP-D899DC2025-11-04
04548736169951SONYUP-D899DC2025-10-06
04548736155091SONYUP-D899MD2025-09-30
04548736155107SONYUP-X899MD2025-09-30
04548736170735SONYLMD-43M1MD2025-09-30
04548736170759SONYLMD-43M1N2025-09-30
04548736170698SONYLMD-27M1MD2025-09-12
04548736170711SONYLMD-27M1N2025-09-12
04548736170728SONYLMD-43M1MD2025-07-08
04548736170742SONYLMD-43M1N2025-07-08
04548736170681SONYLMD-27M1MD2025-06-24
04548736170704SONYLMD-27M1N2025-06-24
04548736167117SONYLMD-32M1MD2025-05-30
04548736167124SONYLMD-32M1N2025-05-30
04548736166059SONYLMD-32M1N2025-04-01
04548736166325SONYLMD-32M1MD2025-03-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16931918170732InvenioGRI Medical & Electronic Technology Co., Ltd.FTA2026-04-17
10748426144560Medline-MicrotekMicrotek Medical LLCFTA2026-02-18
00748426142934Skytron®Microtek Medical LLCFTA2026-02-05
00748426145027NAMicrotek Medical LLCFTA2026-02-05
20748426262704Medline-MicrotekMicrotek Medical LLCFTA2026-01-05
80080196761844MEDLINEMEDLINE INDUSTRIES, INC.FTA2025-11-04
10724995245457HexaLuxSTERIS CORPORATIONFTA2025-05-05
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
16931918159256AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2022-11-26
16931918133201AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2022-11-22
16931918196565AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2022-11-22
00748426118526Skytron Lite-LokMicrotek Medical LLCFTA2022-08-08
10193489003093MEDLINE INDUSTRIESMEDLINE INDUSTRIES, INC.FTA2021-11-03
10193489003109MEDLINE INDUSTRIESMEDLINE INDUSTRIES, INC.FTA2021-11-03
10193489005875MEDLINE INDUSTRIESMEDLINE INDUSTRIES, INC.FTA2021-11-03
00749756725538DeRoyalDEROYAL INDUSTRIES, INC.FTA2021-08-23
G018DLH010Physician's ChoiceSupply Line International Medical, LLCFTA2021-08-05
16931918155524AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2021-04-22
16931918167046AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2021-04-22
16931918173153AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2021-04-22
16931918127309AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2021-03-08
16931918123493B.braunGRI Medical & Electronic Technology Co., Ltd.FTA2021-02-27