Hysteroscopy sheath

GUDID 04059082006536

SOPRO-COMEG GmbH

Endoscope sheath, reusable
Primary Device ID04059082006536
NIH Device Record Key27295e0a-f912-4b09-b75b-be3d5da36b29
Commercial Distribution StatusIn Commercial Distribution
Brand NameHysteroscopy sheath
Version Model Number191 293 052BC
Company DUNS507185952
Company NameSOPRO-COMEG 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 Batchtrue
Serial Numberfalse
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
GS104059082006536 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HIHHYSTEROSCOPE (AND ACCESSORIES)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04059082006536]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-03-11
Device Publish Date2016-12-22

On-Brand Devices [Hysteroscopy sheath]

04059082032672191 423 072
04059082032665191 403 102
04059082032658191 403 100
04059082032641191 403 072
04059082032634191 403 070
04059082032610191 293 052
04059082032597191 273 202
04059082032580191 273 102
04059082032573191 273 100
04059082032566191 273 052
04059082032559191 273 050
04059082032535191 203 060
04059082032528191 203 050
04059082032504191 202 470
04059082007731191 423 072BC
04059082007724191 403 102BC
04059082007717191 403 100BC
04059082007700191 403 072BC
04059082007694191 403 070BC
04059082006536191 293 052BC
04059082006505191 273 202BC
04059082006475191 273 102BC
04059082006451191 273 100BC
04059082006444191 273 052BC
04059082006437191 273 050BC
04059082006086191 203 060BC
04059082006079191 203 050BC
04059082006055191 202 470BC

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