FDA.reportPublic FDA data

N/A

Primary DI
04260491620064
Brand
N/A
Company
Pausch Medical GmbH
Model
03809500
Device description
Cosmos 2, DEL - Bucky left
Published
2017-06-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IYBTube Mount, X-Ray, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYBTube Mount, X-Ray, DiagnosticRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260491620071PackageGS11In Commercial Distribution
04260491620064PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260491620071042604916200714260491620071
04260491620064042604916200644260491620064

GMDN Terms#

Term, Definition table
TermDefinition
X-ray system tube support, floor standingA component of an x-ray system (diagnostic, therapeutic, radiation therapy simulator) intended to be placed on the floor to mount, support and facilitate positioning of the x-ray tube assembly (not included). It typically consists of a rack with controls mounted on a base plate. The x-ray tube assembly is attached to the rack and can be moved along the rack and/or tilted. Some designs also support the movement and positioning of an image receptor assembly (e.g., C-arm assembly).

Regulatory Flags#

DUNS number
342800789
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260491620088N/A011690432019-05-13
04260491620095N/A01169043-S2019-05-13
04260491620118N/A011690442019-05-13
04260491620125N/A01169044-S2019-05-13
04260491620040N/A01169034-S2017-06-08
04260491620002N/A011690332017-06-08
04260491620019N/A01169033-S2017-06-08
04260491620033N/A011690342017-06-08
04260491620057N/A01169034-S2017-06-08
04260491620071N/A038095002017-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809832900302SST-4100SSHINYOUNG FOR M CO.,LTD.IYB2026-05-27
00198953054949NAGE Hualun Medical Systems Co., LtdIYB2025-09-30
00195278901880NAGE Hualun Medical Systems Co., LtdIYB2025-06-09
00860008892768Foot and Ankle StandOXOS Medical, Inc.IYB2025-06-02
08800011103088DRGEMDRGEM CorporationIYB2024-10-24
08800011103095DRGEMDRGEM CorporationIYB2024-10-24
08800011103125DRGEMDRGEM CorporationIYB2024-10-24
08800011103132DRGEMDRGEM CorporationIYB2024-10-24
08800011103163DRGEMDRGEM CorporationIYB2024-10-24
08800011103170DRGEMDRGEM CorporationIYB2024-10-24
08809832900258SD-3100SHINYOUNG FOR M CO.,LTD.IYB2024-04-04
B884SVMS4000VMS 400Pausch, L.L.C.IYB2024-02-16
08809832900074LSS-2000SHINYOUNG FOR M CO.,LTD.IYB2023-11-20
08809832900098SST-3100SHINYOUNG FOR M CO.,LTD.IYB2023-11-20
08809832900104SST-3001SHINYOUNG FOR M CO.,LTD.IYB2023-11-20
08809832900227SS-2100SHINYOUNG FOR M CO.,LTD.IYB2023-11-20
08809832900234SS-2100SHINYOUNG FOR M CO.,LTD.IYB2023-11-20
05999116100269F100 TS99N TUBE MOUNTCONTROL-X Medical Kereskedelmi és Szolgáltató Zártkörűen Működő RészvénytársaságIYB2023-08-15
D678A63410"Provecta HD 16"" Center to Center Wall Mounting Plate"AIR TECHNIQUES, INC.IYB2023-07-11
D678A63890Provecta HD Single Post Mounting PlateAIR TECHNIQUES, INC.IYB2023-07-11
D678A63301Provecta HD 16" Center to Center Wall Mounting PlateAIR TECHNIQUES, INC.IYB2023-07-11
D678A63361Provecta HD Single Post Mounting PlateAIR TECHNIQUES, INC.IYB2023-07-11
B884S10000110R0Paxis 100 AutoPausch, L.L.C.IYB2023-05-12
S10000110R0Paxis 100 AutoPausch, L.L.C.IYB2023-05-03
B884S10000110L0Paxis 100 AutoPausch, L.L.C.IYB2023-05-03
B884S04201000L0CirrusPausch, L.L.C.IYB2022-12-23
B884S04201000R0CirrusPausch, L.L.C.IYB2022-12-23
B884S100002000Paxis 200Pausch, L.L.C.IYB2022-12-23
B884S10000100L0Paxis 100Pausch, L.L.C.IYB2022-12-06
B884S10000100R0Paxis 100Pausch, L.L.C.IYB2022-12-06