FDA.reportPublic FDA data

Zubehoere

Primary DI
04061591000387
Brand
Zubehoere
Company
Ondal Medical Systems GmbH
Model
HD
Published
2020-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FQOTable, Operating-Room, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQOTable, Operating-Room, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04061591000387PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04061591000387040615910003874061591000387

GMDN Terms#

Term, Definition table
TermDefinition
Medical monitor/light mountA permanently-fixed structure designed to support a light and/or an image display monitor that is used for medical purposes [e.g., in an operating room (OR) and/or an examination/treatment room]. The mount is intended to be permanently-fixed to the ceiling and/or wall. This device will be designed to enable dynamic positioning (e.g., with dynamic arms, sliding bracket); the device to be mounted (medical light/monitor) is not included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
313485229
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
04061591000288ValiaBasic2020-08-31
04061591000295ValiaS2020-08-31
04061591001032Multibar040615910010322026-02-02
04061591001292IndependantIDP2025-08-17
04061591001322NuCartNucart2025-03-03
04061591000844MCP Monitor Carrier Program / VALiA Displayw/o CBL2024-06-14
04061591000851MCP Monitor Carrier Program / VALiA Displayw/CBL2024-06-14
04061591000103Acrobat20002020-08-31
04061591000578Zimmer Surgical LightClaro2020-12-04
04061591000004AcrobatSwing2020-08-31
04061591000028Acrobat20002020-08-31
04061591000042WandbefestigungAcrobat2020-08-31
04061591000066DeckenbefestigungSwing2020-08-31
04061591000073Deckenbefestigung20002020-08-31
04061591000080DeckenbefestigungOSP2020-08-31
04061591000110OndaSpaceOSP2020-08-31
04061591000127ZentralachseZA2020-08-31
04061591000202VersorgungskonsoleM62020-08-31
04061591000240CEMORMonitorträger Anschlusstücke2020-08-31
04061591000257VarioViewVV2020-08-31

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