30 Degree Omni Hysteroscope Outflow Channel

GUDID 15420045513655

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
Primary Device ID15420045513655
NIH Device Record Keya262ceda-aab5-4485-b378-5a7dfd6bdf44
Commercial Distribution StatusIn Commercial Distribution
Brand Name30 Degree Omni Hysteroscope Outflow Channel
Version Model Number40-201-30
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
GS115420045513655 [Primary]
GS115420045513655 [Primary]
GS115420045513655 [Primary]
GS115420045513655 [Primary]
GS115420045513655 [Primary]
GS115420045513655 [Primary]
GS115420045513655 [Primary]
GS115420045513655 [Primary]
GS115420045513655 [Primary]
GS115420045513655 [Primary]
GS115420045513655 [Primary]
GS115420045513655 [Primary]
GS115420045513655 [Primary]
GS115420045513655 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HIHHYSTEROSCOPE (AND ACCESSORIES)
HIHHYSTEROSCOPE (AND ACCESSORIES)
HIHHYSTEROSCOPE (AND ACCESSORIES)
HIHHYSTEROSCOPE (AND ACCESSORIES)
HIHHYSTEROSCOPE (AND ACCESSORIES)
HIHHYSTEROSCOPE (AND ACCESSORIES)
HIHHYSTEROSCOPE (AND ACCESSORIES)
HIHHYSTEROSCOPE (AND ACCESSORIES)
HIHHYSTEROSCOPE (AND ACCESSORIES)
HIHHYSTEROSCOPE (AND ACCESSORIES)
HIHHYSTEROSCOPE (AND ACCESSORIES)
HIHHYSTEROSCOPE (AND ACCESSORIES)
HIHHYSTEROSCOPE (AND ACCESSORIES)
HIHHYSTEROSCOPE (AND ACCESSORIES)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[15420045513655]

Moist Heat or Steam Sterilization


[15420045513655]

Moist Heat or Steam Sterilization


[15420045513655]

Moist Heat or Steam Sterilization


[15420045513655]

Moist Heat or Steam Sterilization


[15420045513655]

Moist Heat or Steam Sterilization


[15420045513655]

Moist Heat or Steam Sterilization


[15420045513655]

Moist Heat or Steam Sterilization


[15420045513655]

Moist Heat or Steam Sterilization


[15420045513655]

Moist Heat or Steam Sterilization


[15420045513655]

Moist Heat or Steam Sterilization


[15420045513655]

Moist Heat or Steam Sterilization


[15420045513655]

Moist Heat or Steam Sterilization


[15420045513655]

Moist Heat or Steam Sterilization


[15420045513655]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-15
Device Publish Date2020-10-07

Devices Manufactured by Hologic, Inc.

15420045513563 - 30 Degree Omni Hysteroscope2020-10-15
15420045513624 - 30 Degree 3.7mm Diagnostic Sheath2020-10-15
15420045513631 - 30 Degree 5.5mm operative sheath2020-10-15
15420045513648 - 30 Degree 6mm operative sheath2020-10-15
15420045513655 - 30 Degree Omni Hysteroscope Outflow Channel2020-10-15
15420045513655 - 30 Degree Omni Hysteroscope Outflow Channel2020-10-15
15420045513662 - 30 Degree Omni Hysteroscope XL Outflow Channel2020-10-15
25420045513560 - 30 Degree Omni Hysteroscope2020-10-15
15420045513853 - COMPASS STAINER2020-10-08

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