IMAGE 1 S

GUDID 04048551333150

IMAGE1 S H3-Z FI

Karl Storz GmbH & Co. KG

Endoscope video camera

• Primary Device ID: 04048551333150
• NIH Device Record Key: 6408dd72-4b79-4a73-862a-a06bdb4fc585
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMAGE 1 S
• Version Model Number: TH102
• 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	04048551333150 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131953

FDA Product Code

• OWN: Confocal optical imaging

Sterilization

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

[04048551333150]

Ethylene Oxide;Peracetic Acid;Hydrogen Peroxide

[04048551333150]

Ethylene Oxide;Peracetic Acid;Hydrogen Peroxide

[04048551333150]

Ethylene Oxide;Peracetic Acid;Hydrogen Peroxide

[04048551333150]

Ethylene Oxide;Peracetic Acid;Hydrogen Peroxide

[04048551333150]

Ethylene Oxide;Peracetic Acid;Hydrogen Peroxide

[04048551333150]

Ethylene Oxide;Peracetic Acid;Hydrogen Peroxide

[04048551333150]

Ethylene Oxide;Peracetic Acid;Hydrogen Peroxide

[04048551333150]

Ethylene Oxide;Peracetic Acid;Hydrogen Peroxide

[04048551333150]

Ethylene Oxide;Peracetic Acid;Hydrogen Peroxide

[04048551333150]

Ethylene Oxide;Peracetic Acid;Hydrogen Peroxide

[04048551333150]

Ethylene Oxide;Peracetic Acid;Hydrogen Peroxide

[04048551333150]

Ethylene Oxide;Peracetic Acid;Hydrogen Peroxide

[04048551333150]

Ethylene Oxide;Peracetic Acid;Hydrogen Peroxide

[04048551333150]

Ethylene Oxide;Peracetic Acid;Hydrogen Peroxide

[04048551333150]

Ethylene Oxide;Peracetic Acid;Hydrogen Peroxide

[04048551333150]

Ethylene Oxide;Peracetic Acid;Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-10
• Device Publish Date: 2016-09-23

On-Brand Devices [IMAGE 1 S]

• 04048551333150: IMAGE1 S H3-Z FI
• 04048551370506: IMAGE1 S 4U
• 04048551356876: IMAGE1 S D1
• 04048551333976: IMAGE1 S H3-P
• 04048551333969: IMAGE1 S H3-ZA
• 04048551333143: IMAGE1 S H3-ZI
• 04048551349779: Video Choledochoscope IMAGE1 S