B.I.O.H.

GUDID 04048551257418

B.I.O.H.® Compact Hysteroscope, only

Karl Storz GmbH & Co. KG

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 Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope

• Primary Device ID: 04048551257418
• NIH Device Record Key: 941349e2-82f5-4f4a-b661-82eb1c976320
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: B.I.O.H.
• Version Model Number: 26252BB
• 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	04048551257418 [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

[04048551257418]

Moist Heat or Steam Sterilization

[04048551257418]

Moist Heat or Steam Sterilization

[04048551257418]

Moist Heat or Steam Sterilization

[04048551257418]

Moist Heat or Steam Sterilization

[04048551257418]

Moist Heat or Steam Sterilization

[04048551257418]

Moist Heat or Steam Sterilization

[04048551257418]

Moist Heat or Steam Sterilization

[04048551257418]

Moist Heat or Steam Sterilization

[04048551257418]

Moist Heat or Steam Sterilization

[04048551257418]

Moist Heat or Steam Sterilization

[04048551257418]

Moist Heat or Steam Sterilization

[04048551257418]

Moist Heat or Steam Sterilization

[04048551257418]

Moist Heat or Steam Sterilization

[04048551257418]

Moist Heat or Steam Sterilization

[04048551257418]

Moist Heat or Steam Sterilization

[04048551257418]

Moist Heat or Steam Sterilization

[04048551257418]

Moist Heat or Steam Sterilization

[04048551257418]

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: 2018-08-17

On-Brand Devices [B.I.O.H.]

• 04048551257371: B.I.O.H. Suction and Irrigation Valve
• 04048551257418: B.I.O.H.® Compact Hysteroscope, only