HysteroFlow II

GUDID 04056702001582

W.O.M. World of Medicine GmbH

Hysteroscopic irrigation/insufflation system
Primary Device ID04056702001582
NIH Device Record Key2757e353-280e-4fce-964d-f7ed00713038
Commercial Distribution StatusIn Commercial Distribution
Brand NameHysteroFlow II
Version Model NumberWA40620A
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
GS104056702001582 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HIGInsufflator, Hysteroscopic

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 Date2016-08-09

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

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