AUTOCON

GUDID 04048551378809

AUTOCON® III 400

Karl Storz GmbH & Co. KG

Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator

• Primary Device ID: 04048551378809
• NIH Device Record Key: 12bd0ea0-2bf0-477a-988e-d4033960ddde
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AUTOCON
• Version Model Number: UH400U
• 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	04048551378809 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171717

FDA Product Code

• GEI: Electrosurgical, cutting & coagulation & accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-04-04
• Device Publish Date: 2018-08-21

Devices Manufactured by Karl Storz GmbH & Co. KG

• 04048438000984 - n.a.: 2024-03-19 Patient Tubing Set, for day sets
• 04048438001042 - n.a.: 2024-03-19 Tubing Set, UNIDRIVE/UNIDRIVE SIII
• 04048438001233 - n.a.: 2024-03-19 Gas filter, gas flow 30 l/min
• 04048438002230 - n.a.: 2024-03-19 Tubing Set, CLEARVISION II (irrigation)
• 04048438002964 - n.a.: 2024-03-19 Tubing Set, ARTHROPUMP Power(irrigation)
• 04048438003176 - n.a.: 2024-03-19 Pump Tubing Day Set
• 04048438005316 - n.a.: 2024-03-19 Insufflation Tubing Set, with gas filter
• 04048438005330 - n.a.: 2024-03-19 Insufflation tubing set, ENDOFLATOR 50