Pump for Arthroscopy

GUDID 04056702003364

W.O.M. World of Medicine GmbH

Arthroscopic irrigation/insufflation system
Primary Device ID04056702003364
NIH Device Record Key1af8d97f-5090-4230-94d7-42d3324db072
Commercial Distribution StatusIn Commercial Distribution
Brand NamePump for Arthroscopy
Version Model NumberA127
Company DUNS316305242
Company NameW.O.M. World of Medicine 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 Datetrue
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
GS104056702003364 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRXArthroscope

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 Date2016-08-23

Devices Manufactured by W.O.M. World of Medicine GmbH

04056702008789 - Heating tube set for insufflation, single use2020-11-09
04056702008802 - Tube set for insufflation, single-use2020-11-09
04056702008826 - Tube set for suction, single-use2020-11-09
04056702008840 - Tube set for suction (with 2 ports), single-use2020-11-09
04056702008864 - Tube set for irrigation, single-use2020-11-09
04056702008888 - Tube set for vacuum incl. filter, 30-day use2020-11-09
04056702008895 - Insufflator 50L2020-11-09
04056702008901 - ARTHRO-Pump2020-11-09

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