Omni Hysteroscopy Light Set

GUDID 15420045510340

Hologic, Inc.

Rigid optical hysteroscope
Primary Device ID15420045510340
NIH Device Record Keye9abff9b-facd-4ed8-acb7-7b2d94e1e15e
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmni Hysteroscopy Light Set
Version Model Number60-250-2
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 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
GS115420045510340 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HIHHYSTEROSCOPE (AND ACCESSORIES)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[15420045510340]

Moist Heat or Steam Sterilization


[15420045510340]

Moist Heat or Steam Sterilization


[15420045510340]

Moist Heat or Steam Sterilization


[15420045510340]

Moist Heat or Steam Sterilization


[15420045510340]

Moist Heat or Steam Sterilization


[15420045510340]

Moist Heat or Steam Sterilization


[15420045510340]

Moist Heat or Steam Sterilization


[15420045510340]

Moist Heat or Steam Sterilization


[15420045510340]

Moist Heat or Steam Sterilization


[15420045510340]

Moist Heat or Steam Sterilization


[15420045510340]

Moist Heat or Steam Sterilization


[15420045510340]

Moist Heat or Steam Sterilization


[15420045510340]

Moist Heat or Steam Sterilization


[15420045510340]

Moist Heat or Steam Sterilization


[15420045510340]

Moist Heat or Steam Sterilization


[15420045510340]

Moist Heat or Steam Sterilization


[15420045510340]

Moist Heat or Steam Sterilization


[15420045510340]

Moist Heat or Steam Sterilization


[15420045510340]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-08
Device Publish Date2018-12-10

On-Brand Devices [Omni Hysteroscopy Light Set]

1542004551034060-250-2
25420045510347The OMNI™Hysteroscope is used to provide viewing of the cervical canal and the uterine cavity

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