FDA.reportPublic FDA data

N/A

Primary DI
04260491620118
Brand
N/A
Company
Pausch Medical GmbH
Model
01169044
Device description
Uroview FD II Left Configuration. Part of 01169044-S.
Published
2019-05-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JAASystem, X-Ray, Fluoroscopic, Image-Intensified

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAASystem, X-Ray, Fluoroscopic, Image-IntensifiedRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180651000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180651000Uroview FD IIPausch Medical GmbH2018-04-12JAA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260491620118PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260491620118042604916201184260491620118

GMDN Terms#

Term, Definition table
TermDefinition
Stationary uro-gynaecological fluoroscopic x-ray system, digitalA stationary diagnostic x-ray system with real-time fluoroscopic capabilities specifically designed for use in urological and/or gynaecological surgical and interventional procedures requiring real-time visualization of the pelvic area. It uses digital techniques for real-time image capture, display and manipulation and include spot-film capabilities as well as fluoroscopic features. It is commonly used for imaging and x-ray guided surgical or interventional procedures. The images can be viewed in both real-time and delayed formats and may include various levels of imaging processing and analysis capabilities.

Regulatory Flags#

DUNS number
342800789
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260491620064N/A038095002017-06-08
04260491620088N/A011690432019-05-13
04260491620095N/A01169043-S2019-05-13
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

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