N/A

GUDID 04260491620057

Complete System Uroview FD Left Configuration

Pausch Medical GmbH

Stationary uro-gynaecological fluoroscopic x-ray system, digital
Primary Device ID04260491620057
NIH Device Record Key18e06d46-6fe4-4dd0-b5c4-d7d9b1e41d79
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model Number01169034-S
Company DUNS342800789
Company NamePausch Medical GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104260491620040 [Primary]
GS104260491620057 [Package]
Contains: 04260491620040
Package: [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAASystem, X-Ray, Fluoroscopic, Image-Intensified

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-06-08

On-Brand Devices [N/A]

04260491620071Cosmos 2, DEL - Bucky left
04260491620057Complete System Uroview FD Left Configuration
04260491620033Uroview FD Left Configuration. Part of 01169034-S
04260491620019Complete System Uroview FD Right Configuration
04260491620002Uroview FD Right Configuration. Part of 01169033-S

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.