SILVER SCOPE

GUDID 04048551003633

Gastroscope 9.3/2.8/1100 NTSC

Karl Storz GmbH & Co. KG

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

[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

[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
• 04048551360316: Slim colonoscpe 11,2/3,4/1530 NTSC
• 04048551003701: Standard Colonoscope 3.8/1600 PAL
• 04048551003695: Standard Colonoscope 3.8/1600 NTSC