FDA.reportPublic FDA data

SONY

Primary DI
04905524846034
Brand
SONY
Company
SONY CORPORATION
Model
PVM-2551MD
Device description
25 Inch OLED Medical Grade LCD Monitor
Published
2016-09-16
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
FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FETEndoscopic Video Imaging System/Component, Gastroenterology-UrologyGastroenterology, Urology2
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120611000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120611000SONY PVM-2551MD OLED MONITORSony Electronics, Inc.2012-06-28GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04905524846034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04905524846034049055248460344905524846034

GMDN Terms#

Term, Definition table
TermDefinition
Image display monitor, colourA mains electricity (AC-powered) visual display unit (VDU), commonly known as a screen or a monitor, used for displaying graphical information under program control in colour, e.g., measured values or images from other devices. Colour is necessary when separating the information of multiple parameters making it easier for the user to read the values. A keyboard may be connected to the unit for interactive manipulation of the data by an operator. This GMDN code is the product identifier for the monitor only, which will not include the device(s) from which the data is generated and includes different screen technologies, e.g., cathode-ray tube (CRT) or liquid crystal display (LCD).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690553649
Device count
1
Serial number
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
00198506044366ELMEDELMED INCORPORATEDGCJ2026-06-09
00812231033906PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231033913PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231033920PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231034095PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231034101PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
04717480900336Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900343Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900350Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900367Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900398Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900404Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900763Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900770Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900787Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900800Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
E496C05HPDH0Handle for pneumodissection HookAB MEDICAGCJ2026-06-08
E496C05IDCH20ST1Hook insert and tube for pneumodissection D=5,0mm Lg=20cm, sterile single useAB MEDICAGCJ2026-06-08
E496C05IDCH33ST1Hook insert and tube for pneumodissection D=5,0mm Lg=33cm, sterile single useAB MEDICAGCJ2026-06-08
E496C35IDCH20ST1Hook insert and tube for pneumodissection D=3,5mm Lg=20cm, sterile single useAB MEDICAGCJ2026-06-08
E496C35IDCH33ST1Hook insert and tube for pneumodissection D=3,5mm Lg=33cm, sterile single useAB MEDICAGCJ2026-06-08
00198506091414ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-05
00198506091421ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-05
00198506091438ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-05
00198506091247ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-03
00198506091254ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-03
00192896123427TrocarSONTEC INSTRUMENTS, INC.GCJ2026-06-02
00192896123434Flexible Trocar SleeveSONTEC INSTRUMENTS, INC.GCJ2026-06-02
E496C35BTU200C35-Bipolar Tube L 20cm D 3,5mmAB MEDICAGCJ2026-05-28
E496C35IBDM200C35- Bipolar Maryland Insert L20cm D 3,5mmAB MEDICAGCJ2026-05-28