ENDOCAMELEON 28140EWK

GUDID 04048551360231

Changing Rod ENDOCAMELEON, cannulated

Karl Storz GmbH & Co. KG

Arthroscopic access cannula, reusable

• Primary Device ID: 04048551360231
• NIH Device Record Key: c12cac4c-9274-46b4-a0e2-893917b2ef8f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOCAMELEON
• Version Model Number: 28140EWK
• Catalog Number: 28140EWK
• 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: true
• Serial Number: false
• 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

Customer Support Contacts

• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048551360231 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K954981

FDA Product Code

• HRX: Arthroscope

Sterilization

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

[04048551360231]

Moist Heat or Steam Sterilization

[04048551360231]

Moist Heat or Steam Sterilization

[04048551360231]

Moist Heat or Steam Sterilization

[04048551360231]

Moist Heat or Steam Sterilization

[04048551360231]

Moist Heat or Steam Sterilization

[04048551360231]

Moist Heat or Steam Sterilization

[04048551360231]

Moist Heat or Steam Sterilization

[04048551360231]

Moist Heat or Steam Sterilization

[04048551360231]

Moist Heat or Steam Sterilization

[04048551360231]

Moist Heat or Steam Sterilization

[04048551360231]

Moist Heat or Steam Sterilization

[04048551360231]

Moist Heat or Steam Sterilization

[04048551360231]

Moist Heat or Steam Sterilization

[04048551360231]

Moist Heat or Steam Sterilization

[04048551360231]

Moist Heat or Steam Sterilization

[04048551360231]

Moist Heat or Steam Sterilization

[04048551360231]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-08-01
• Device Publish Date: 2018-08-21

On-Brand Devices [ENDOCAMELEON]

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