30 Degree Omni Hysteroscope

GUDID 25420045513560

Hologic, Inc.

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Primary Device ID25420045513560
NIH Device Record Key19b74407-7e15-4abe-a58a-40d323418ef3
Commercial Distribution StatusIn Commercial Distribution
Brand Name30 Degree Omni Hysteroscope
Version Model Number60-200-30
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 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
GS125420045513560 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HIHHYSTEROSCOPE (AND ACCESSORIES)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[25420045513560]

Moist Heat or Steam Sterilization


[25420045513560]

Moist Heat or Steam Sterilization


[25420045513560]

Moist Heat or Steam Sterilization


[25420045513560]

Moist Heat or Steam Sterilization


[25420045513560]

Moist Heat or Steam Sterilization


[25420045513560]

Moist Heat or Steam Sterilization


[25420045513560]

Moist Heat or Steam Sterilization


[25420045513560]

Moist Heat or Steam Sterilization


[25420045513560]

Moist Heat or Steam Sterilization


[25420045513560]

Moist Heat or Steam Sterilization


[25420045513560]

Moist Heat or Steam Sterilization


[25420045513560]

Moist Heat or Steam Sterilization


[25420045513560]

Moist Heat or Steam Sterilization


[25420045513560]

Moist Heat or Steam Sterilization


[25420045513560]

Moist Heat or Steam Sterilization


[25420045513560]

Moist Heat or Steam Sterilization


[25420045513560]

Moist Heat or Steam Sterilization


[25420045513560]

Moist Heat or Steam Sterilization


[25420045513560]

Moist Heat or Steam Sterilization


[25420045513560]

Moist Heat or Steam Sterilization


[25420045513560]

Moist Heat or Steam Sterilization


[25420045513560]

Moist Heat or Steam Sterilization


[25420045513560]

Moist Heat or Steam Sterilization


[25420045513560]

Moist Heat or Steam Sterilization


[25420045513560]

Moist Heat or Steam Sterilization


[25420045513560]

Moist Heat or Steam Sterilization


[25420045513560]

Moist Heat or Steam Sterilization


[25420045513560]

Moist Heat or Steam Sterilization


[25420045513560]

Moist Heat or Steam Sterilization


[25420045513560]

Moist Heat or Steam Sterilization


[25420045513560]

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

On-Brand Devices [30 Degree Omni Hysteroscope]

2542004551356060-200-30
1542004551356360-200-30

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