HAMOU / HOPKINS

GUDID 04048551093856

Examination and Contact Hysteroscope

Karl Storz GmbH & Co. KG

Rigid optical hysteroscope

Primary Device ID	04048551093856
NIH Device Record Key	ccf1b0a6-d01e-4fad-ac05-f96c606eee5e
Commercial Distribution Status	In Commercial Distribution
Brand Name	HAMOU / HOPKINS
Version Model Number	26120BHA
Company DUNS	315731430
Company Name	Karl Storz GmbH & Co. KG
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048551093856 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K943176

FDA Product Code

FAJ	Cystoscope and accessories, flexible/rigid

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[04048551093856]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide;Liquid Chemical

[04048551093856]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide;Liquid Chemical

[04048551093856]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide;Liquid Chemical

[04048551093856]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide;Liquid Chemical

[04048551093856]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide;Liquid Chemical

[04048551093856]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide;Liquid Chemical

[04048551093856]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide;Liquid Chemical

[04048551093856]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide;Liquid Chemical

[04048551093856]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide;Liquid Chemical

[04048551093856]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide;Liquid Chemical

[04048551093856]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide;Liquid Chemical

[04048551093856]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide;Liquid Chemical

[04048551093856]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide;Liquid Chemical

[04048551093856]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide;Liquid Chemical

[04048551093856]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide;Liquid Chemical

[04048551093856]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide;Liquid Chemical

[04048551093856]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide;Liquid Chemical

[04048551093856]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide;Liquid Chemical

[04048551093856]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide;Liquid Chemical

[04048551093856]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide;Liquid Chemical

[04048551093856]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide;Liquid Chemical

[04048551093856]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide;Liquid Chemical

[04048551093856]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide;Liquid Chemical

[04048551093856]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide;Liquid Chemical

[04048551093856]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide;Liquid Chemical

[04048551093856]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide;Liquid Chemical

[04048551093856]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide;Liquid Chemical

[04048551093856]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide;Liquid Chemical

[04048551093856]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide;Liquid Chemical

[04048551093856]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide;Liquid Chemical

[04048551093856]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide;Liquid Chemical

[04048551093856]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide;Liquid Chemical

[04048551093856]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide;Liquid Chemical

[04048551093856]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide;Liquid Chemical

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2019-11-08
Device Publish Date	2016-09-23

On-Brand Devices [HAMOU / HOPKINS]

04048551094198	Operating and Contact Hysteroscope
04048551093856	Examination and Contact Hysteroscope

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