Galileo Colposcope, Direct Access

GUDID GYNX400LDAT0

GYNEX CORPORATION

Colposcope
Primary Device IDGYNX400LDAT0
NIH Device Record Key71e01207-6159-4341-a127-f151ee8b52cf
Commercial Distribution StatusIn Commercial Distribution
Brand NameGalileo Colposcope, Direct Access
Version Model Number400LDA-T
Company DUNS012997685
Company NameGYNEX CORPORATION
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCGYNX400LDAT0 [Primary]

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 Number2
Public Version Date2018-03-29
Device Publish Date2016-10-05

On-Brand Devices [Galileo Colposcope, Direct Access]

GYNX430VCDAT0430VCDA-T
GYNX430VCDAR0430VCDA-R
GYNX430LVCDAT0430LVCDA-T
GYNX430LVCDAR0430LVCDA-R
GYNX400LDAT0400LDA-T
GYNX400DAT0400DA-T
GYNX400DAR0400DA-R
GYNX200LDAT0200LDA-T
GYNX200LDAR0200LDA-R
GYNX200DAT0200DA-T
GYNX200DAR0200DA-R

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