ENDOCAMELEON

GUDID 04048551317563

ENDOCAMELEON® ENT HOPKINS® Telescope

Karl Storz GmbH & Co. KG

Rigid rhinoscope

• Primary Device ID: 04048551317563
• NIH Device Record Key: ee476738-b9b8-4269-90c0-be0241ae8bf3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOCAMELEON
• Version Model Number: 7230AE
• 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	04048551317563 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K945788

FDA Product Code

• EOB: NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)

Sterilization

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

[04048551317563]

Moist Heat or Steam Sterilization

[04048551317563]

Moist Heat or Steam Sterilization

[04048551317563]

Moist Heat or Steam Sterilization

[04048551317563]

Moist Heat or Steam Sterilization

[04048551317563]

Moist Heat or Steam Sterilization

[04048551317563]

Moist Heat or Steam Sterilization

[04048551317563]

Moist Heat or Steam Sterilization

[04048551317563]

Moist Heat or Steam Sterilization

[04048551317563]

Moist Heat or Steam Sterilization

[04048551317563]

Moist Heat or Steam Sterilization

[04048551317563]

Moist Heat or Steam Sterilization

[04048551317563]

Moist Heat or Steam Sterilization

[04048551317563]

Moist Heat or Steam Sterilization

[04048551317563]

Moist Heat or Steam Sterilization

[04048551317563]

Moist Heat or Steam Sterilization

[04048551317563]

Moist Heat or Steam Sterilization

[04048551317563]

Moist Heat or Steam Sterilization

[04048551317563]

Moist Heat or Steam Sterilization

[04048551317563]

Moist Heat or Steam Sterilization

[04048551317563]

Moist Heat or Steam Sterilization

[04048551317563]

Moist Heat or Steam Sterilization

[04048551317563]

Moist Heat or Steam Sterilization

[04048551317563]

Moist Heat or Steam Sterilization

[04048551317563]

Moist Heat or Steam Sterilization

[04048551317563]

Moist Heat or Steam Sterilization

[04048551317563]

Moist Heat or Steam Sterilization

[04048551317563]

Moist Heat or Steam Sterilization

[04048551317563]

Moist Heat or Steam Sterilization

[04048551317563]

Moist Heat or Steam Sterilization

[04048551317563]

Moist Heat or Steam Sterilization

[04048551317563]

Moist Heat or Steam Sterilization

[04048551317563]

Moist Heat or Steam Sterilization

[04048551317563]

Moist Heat or Steam Sterilization

[04048551317563]

Moist Heat or Steam Sterilization

[04048551317563]

Moist Heat or Steam Sterilization

[04048551317563]

Moist Heat or Steam Sterilization

[04048551317563]

Moist Heat or Steam Sterilization

[04048551317563]

Moist Heat or Steam Sterilization

[04048551317563]

Moist Heat or Steam Sterilization

[04048551317563]

Moist Heat or Steam Sterilization

[04048551317563]

Moist Heat or Steam Sterilization

[04048551317563]

Moist Heat or Steam Sterilization

[04048551317563]

Moist Heat or Steam Sterilization

[04048551317563]

Moist Heat or Steam Sterilization

[04048551317563]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-10-06
• Device Publish Date: 2016-09-23

On-Brand Devices [ENDOCAMELEON]

• 04048551326572: ENDOCAMELEON® HOPKINS® Telescope
• 04048551317563: ENDOCAMELEON® ENT HOPKINS® Telescope
• 04048551360231: Changing Rod ENDOCAMELEON, cannulated
• 04048551327319: Arthroscope Sheath ENDOCAMELEON®