FDA.reportPublic FDA data

N/A

Primary DI
04260491620057
Brand
N/A
Company
Pausch Medical GmbH
Model
01169034-S
Device description
Complete System Uroview FD Left Configuration
Published
2017-06-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
K161019000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161019000Uroview FDPausch Medical GmbH2016-08-17JAA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260491620057PackageGS11In Commercial Distribution
04260491620040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260491620057042604916200574260491620057
04260491620040042604916200404260491620040

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
342800789
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
04260491620071N/A038095002017-06-08

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