HAMOU / HOPKINS

GUDID 04048551094198

Operating and Contact Hysteroscope

Karl Storz GmbH & Co. KG

Rigid optical hysteroscope

• Primary Device ID: 04048551094198
• NIH Device Record Key: 2a920e88-a78e-40e6-aa68-d871f54bec89
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HAMOU / HOPKINS
• Version Model Number: 26157BTA
• 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	04048551094198 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K935716

FDA Product Code

• HIH: HYSTEROSCOPE (AND ACCESSORIES)

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[04048551094198]

Moist Heat or Steam Sterilization

[04048551094198]

Moist Heat or Steam Sterilization

[04048551094198]

Moist Heat or Steam Sterilization

[04048551094198]

Moist Heat or Steam Sterilization

[04048551094198]

Moist Heat or Steam Sterilization

[04048551094198]

Moist Heat or Steam Sterilization

[04048551094198]

Moist Heat or Steam Sterilization

[04048551094198]

Moist Heat or Steam Sterilization

[04048551094198]

Moist Heat or Steam Sterilization

[04048551094198]

Moist Heat or Steam Sterilization

[04048551094198]

Moist Heat or Steam Sterilization

[04048551094198]

Moist Heat or Steam Sterilization

[04048551094198]

Moist Heat or Steam Sterilization

[04048551094198]

Moist Heat or Steam Sterilization

[04048551094198]

Moist Heat or Steam Sterilization

[04048551094198]

Moist Heat or Steam Sterilization

[04048551094198]

Moist Heat or Steam Sterilization

[04048551094198]

Moist Heat or Steam Sterilization

[04048551094198]

Moist Heat or Steam Sterilization

[04048551094198]

Moist Heat or Steam Sterilization

[04048551094198]

Moist Heat or Steam Sterilization

[04048551094198]

Moist Heat or Steam Sterilization

[04048551094198]

Moist Heat or Steam Sterilization

[04048551094198]

Moist Heat or Steam Sterilization

[04048551094198]

Moist Heat or Steam Sterilization

[04048551094198]

Moist Heat or Steam Sterilization

[04048551094198]

Moist Heat or Steam Sterilization

[04048551094198]

Moist Heat or Steam Sterilization

[04048551094198]

Moist Heat or Steam Sterilization

[04048551094198]

Moist Heat or Steam Sterilization

[04048551094198]

Moist Heat or Steam Sterilization

[04048551094198]

Moist Heat or Steam Sterilization

[04048551094198]

Moist Heat or Steam Sterilization

[04048551094198]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2018-08-21

On-Brand Devices [HAMOU / HOPKINS]

• 04048551094198: Operating and Contact Hysteroscope
• 04048551093856: Examination and Contact Hysteroscope