ColpoStar™ 1H Colposcope

GUDID 00888937014723

ColpoStar™ 1H Colposcope with Traditional Halogen Light

Coopersurgical, Inc.

Colposcope
Primary Device ID00888937014723
NIH Device Record Keyf67c8e32-c13d-4dec-85ee-684a1ebe398b
Commercial Distribution StatusIn Commercial Distribution
Brand NameColpoStar™ 1H Colposcope
Version Model Number906135
Company DUNS801895244
Company NameCoopersurgical, Inc.
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 Datefalse
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
GS100888937014723 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HEXColposcope (And Colpomicroscope)

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 Date2016-11-17

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