Synergy Insufflation

GUDID 04056702002824

W.O.M. World of Medicine GmbH

Laparoscopic insufflator
Primary Device ID04056702002824
NIH Device Record Keydc37eae7-1d09-4bd8-9935-dfe0dccd6a8f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSynergy Insufflation
Version Model NumberFM134
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
GS104056702002824 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HIFInsufflator, Laparoscopic

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 Date2016-08-10

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

04056702012861 - GYN-Pump2024-07-08
04056702012878 - Fluid Monitoring Unit2024-07-08
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

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