MyoSure Tissue Removal Device 50-401XL

GUDID 15420045505087

Hologic, Inc.

Tissue morcellation system handpiece set
Primary Device ID15420045505087
NIH Device Record Key6532d9a1-1715-4a76-8aed-9bd911af4928
Commercial Distribution StatusIn Commercial Distribution
Brand NameMyoSure Tissue Removal Device
Version Model Number50-401XL
Catalog Number50-401XL
Company DUNS018925968
Company NameHologic, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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
GS115420045505087 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HIHHYSTEROSCOPE (AND ACCESSORIES)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[15420045505087]

Ethylene Oxide


[15420045505087]

Ethylene Oxide


[15420045505087]

Ethylene Oxide


[15420045505087]

Ethylene Oxide


[15420045505087]

Ethylene Oxide


[15420045505087]

Ethylene Oxide


[15420045505087]

Ethylene Oxide


[15420045505087]

Ethylene Oxide


[15420045505087]

Ethylene Oxide


[15420045505087]

Ethylene Oxide


[15420045505087]

Ethylene Oxide


[15420045505087]

Ethylene Oxide


[15420045505087]

Ethylene Oxide


[15420045505087]

Ethylene Oxide


[15420045505087]

Ethylene Oxide


[15420045505087]

Ethylene Oxide


[15420045505087]

Ethylene Oxide


[15420045505087]

Ethylene Oxide


[15420045505087]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-02-10

On-Brand Devices [MyoSure Tissue Removal Device]

2542004550510740-902
1542004550509450-501XL
1542004550508750-401XL
1542004550507030-401LITE
1542004550481310-401

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