SILVER SCOPE

GUDID 04048551003633

Gastroscope 9.3/2.8/1100 NTSC

Karl Storz GmbH & Co. KG

Flexible video gastroscope, reusable Flexible video gastroscope, reusable Flexible video gastroscope, reusable Flexible video gastroscope, reusable Flexible video gastroscope, reusable Flexible video gastroscope, reusable Flexible video gastroscope, reusable Flexible video gastroscope, reusable Flexible video gastroscope, reusable Flexible video gastroscope, reusable Flexible video gastroscope, reusable

• Primary Device ID: 04048551003633
• NIH Device Record Key: df216697-de8a-453d-922d-eb9e09c45038
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SILVER SCOPE
• Version Model Number: 13821NKS
• 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	04048551003633 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060907

FDA Product Code

• FDS: Gastroscope and accessories, flexible/rigid

Sterilization

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

[04048551003633]

Ethylene Oxide;Peracetic Acid;Liquid Chemical;Hydrogen Peroxide

[04048551003633]

Ethylene Oxide;Peracetic Acid;Liquid Chemical;Hydrogen Peroxide

[04048551003633]

Ethylene Oxide;Peracetic Acid;Liquid Chemical;Hydrogen Peroxide

[04048551003633]

Ethylene Oxide;Peracetic Acid;Liquid Chemical;Hydrogen Peroxide

[04048551003633]

Ethylene Oxide;Peracetic Acid;Liquid Chemical;Hydrogen Peroxide

[04048551003633]

Ethylene Oxide;Peracetic Acid;Liquid Chemical;Hydrogen Peroxide

[04048551003633]

Ethylene Oxide;Peracetic Acid;Liquid Chemical;Hydrogen Peroxide

[04048551003633]

Ethylene Oxide;Peracetic Acid;Liquid Chemical;Hydrogen Peroxide

[04048551003633]

Ethylene Oxide;Peracetic Acid;Liquid Chemical;Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-02-05
• Device Publish Date: 2016-09-23

On-Brand Devices [SILVER SCOPE]

• 04048551390221: Medium Gastroscope 7.8/2.8/1100 NTSC
• 04048551003633: Gastroscope 9.3/2.8/1100 NTSC
• 04048551003619: Slim Gastroscope, 5.9/2/1100/NTSC
• 04048551390443: Sigmoidoscope 11.2/3.4/800 NTSC