TRICAM®

GUDID 04048551350652

CCU,TRICAM SL II,USA

Karl Storz GmbH & Co. KG

Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit

• Primary Device ID: 04048551350652
• NIH Device Record Key: b437ff72-00d2-4655-be3a-b18da1dd73d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRICAM®
• Version Model Number: 20223020-134
• 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: true
• 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: 424-218-8201
• Email: su.chen@karlstorz.com
• Phone: 424-218-8201
• Email: su.chen@karlstorz.com
• Phone: 424-218-8201
• Email: su.chen@karlstorz.com
• Phone: 424-218-8201
• Email: su.chen@karlstorz.com
• Phone: 424-218-8201
• Email: su.chen@karlstorz.com
• Phone: 424-218-8201
• Email: su.chen@karlstorz.com
• Phone: 424-218-8201
• Email: su.chen@karlstorz.com
• Phone: 424-218-8201
• Email: su.chen@karlstorz.com
• Phone: 424-218-8201
• Email: su.chen@karlstorz.com
• Phone: 424-218-8201
• Email: su.chen@karlstorz.com
• Phone: 424-218-8201
• Email: su.chen@karlstorz.com
• Phone: 424-218-8201
• Email: su.chen@karlstorz.com
• Phone: 424-218-8201
• Email: su.chen@karlstorz.com
• Phone: 424-218-8201
• Email: su.chen@karlstorz.com
• Phone: 424-218-8201
• Email: su.chen@karlstorz.com
• Phone: 424-218-8201
• Email: su.chen@karlstorz.com
• Phone: 424-218-8201
• Email: su.chen@karlstorz.com
• Phone: 424-218-8201
• Email: su.chen@karlstorz.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048551350652 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P050027

FDA Product Code

• OAY: Light Source System, Diagnostic Endoscopic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-11
• 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