TRICAM® 20221137

GUDID 04048551064085

TRICAM PDD/AF Camera Head NTSC

Karl Storz GmbH & Co. KG

Endoscope video camera

• Primary Device ID: 04048551064085
• NIH Device Record Key: b2d35df2-0b07-4e4d-938d-7829e8d29ecd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRICAM®
• Version Model Number: 20221137
• Catalog Number: 20221137
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048551064085 [Primary]

FDA Product Code

• OAY: Light Source System, Diagnostic Endoscopic

Sterilization

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

[04048551064085]

Hydrogen Peroxide;High-level Disinfectant;Ethylene Oxide

[04048551064085]

Hydrogen Peroxide;High-level Disinfectant;Ethylene Oxide

[04048551064085]

Hydrogen Peroxide;High-level Disinfectant;Ethylene Oxide

[04048551064085]

Hydrogen Peroxide;High-level Disinfectant;Ethylene Oxide

[04048551064085]

Hydrogen Peroxide;High-level Disinfectant;Ethylene Oxide

[04048551064085]

Hydrogen Peroxide;High-level Disinfectant;Ethylene Oxide

[04048551064085]

Hydrogen Peroxide;High-level Disinfectant;Ethylene Oxide

[04048551064085]

Hydrogen Peroxide;High-level Disinfectant;Ethylene Oxide

[04048551064085]

Hydrogen Peroxide;High-level Disinfectant;Ethylene Oxide

[04048551064085]

Hydrogen Peroxide;High-level Disinfectant;Ethylene Oxide

[04048551064085]

Hydrogen Peroxide;High-level Disinfectant;Ethylene Oxide

[04048551064085]

Hydrogen Peroxide;High-level Disinfectant;Ethylene Oxide

[04048551064085]

Hydrogen Peroxide;High-level Disinfectant;Ethylene Oxide

[04048551064085]

Hydrogen Peroxide;High-level Disinfectant;Ethylene Oxide

[04048551064085]

Hydrogen Peroxide;High-level Disinfectant;Ethylene Oxide

[04048551064085]

Hydrogen Peroxide;High-level Disinfectant;Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2022-02-21
• Device Publish Date: 2014-09-24

On-Brand Devices [TRICAM® ]

• 04048551350652: CCU,TRICAM SL II,USA
• 04048551064160: CCU, TRICAM®, SL II, SCB
• 04048551064092: TRICAM-P PDD/AF Camera Head NTSC
• 04048551064085: TRICAM PDD/AF Camera Head NTSC