TC028

GUDID 04048551439043

E-BOX for X-LINK

Karl Storz GmbH & Co. KG

Endoscope video camera

• Primary Device ID: 04048551439043
• NIH Device Record Key: 308a449a-0379-4f3b-8798-adab2284bf34
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: TC028
• Catalog Number: TC028
• Company DUNS: 315731430
• Company Name: Karl Storz GmbH & Co. KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048551439043 [Primary]

FDA Product Code

• FGB: Ureteroscope and accessories, flexible/rigid

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-04
• Device Publish Date: 2025-03-27

Devices Manufactured by Karl Storz GmbH & Co. KG

• 04048438008867 - NA: 2025-04-07 C-MAC S Video Laryngoscope MILLER #1
• 04048438008911 - NA: 2025-04-07 C-MAC S Video Laryngoscope MILLER #0
• 04048551010242 - NA: 2025-04-07 Telescope Protective Sheath for 497HC
• 04048551012468 - NA: 2025-04-07 Irrigation Tube, for cleaning
• 04048551061343 - NA: 2025-04-07 15 Touch Screen
• 04048551067444 - NA: 2025-04-07 CO2 High Pressure Hose, American/Germ.
• 04048551069493 - NA: 2025-04-07 Mandrin, for 204808
• 04048551069530 - NA: 2025-04-07 Mandrin, for 204809