MyoSure XL Rod Lens Hysteroscope Outflow Channel

GUDID 15420045510234

Hologic, Inc.

Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope
Primary Device ID15420045510234
NIH Device Record Key573ea8b5-be9e-4e39-b5aa-e6efd843d87e
Commercial Distribution StatusIn Commercial Distribution
Brand NameMyoSure XL Rod Lens Hysteroscope Outflow Channel
Version Model Number50-201XL
Company DUNS018925968
Company NameHologic, 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 Batchtrue
Serial Numberfalse
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
GS115420045510234 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HIHHYSTEROSCOPE (AND ACCESSORIES)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[15420045510234]

Moist Heat or Steam Sterilization


[15420045510234]

Moist Heat or Steam Sterilization


[15420045510234]

Moist Heat or Steam Sterilization


[15420045510234]

Moist Heat or Steam Sterilization


[15420045510234]

Moist Heat or Steam Sterilization


[15420045510234]

Moist Heat or Steam Sterilization


[15420045510234]

Moist Heat or Steam Sterilization


[15420045510234]

Moist Heat or Steam Sterilization


[15420045510234]

Moist Heat or Steam Sterilization


[15420045510234]

Moist Heat or Steam Sterilization


[15420045510234]

Moist Heat or Steam Sterilization


[15420045510234]

Moist Heat or Steam Sterilization


[15420045510234]

Moist Heat or Steam Sterilization


[15420045510234]

Moist Heat or Steam Sterilization


[15420045510234]

Moist Heat or Steam Sterilization


[15420045510234]

Moist Heat or Steam Sterilization


[15420045510234]

Moist Heat or Steam Sterilization


[15420045510234]

Moist Heat or Steam Sterilization


[15420045510234]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-11-08
Device Publish Date2018-10-03

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