GYN-Pump

GUDID 04056702012861

W.O.M. World of Medicine GmbH

Hysteroscopic irrigation/insufflation system
Primary Device ID04056702012861
NIH Device Record Key5400bd49-3660-476a-b610-f712b12c4052
Commercial Distribution StatusIn Commercial Distribution
Brand NameGYN-Pump
Version Model NumberPH304
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104056702012861 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-08
Device Publish Date2024-06-28

On-Brand Devices [GYN-Pump]

04056702004705PH304
04056702012861PH304

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