UNIDRIVE

GUDID 04048551071601

Unidrive ENT with SCB

Karl Storz GmbH & Co. KG

ENT shaver system

• Primary Device ID: 04048551071601
• NIH Device Record Key: 4225724b-f5cc-448e-8cb6-c77b384e5a9a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNIDRIVE
• Version Model Number: 20711620-1
• 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	04048551071601 [Primary]

FDA Product Code

• ERL: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-10-21
• Device Publish Date: 2016-09-23

On-Brand Devices [UNIDRIVE]

• 04048551278802: UNIDRIVE® S III Motor System
• 04048551277287: Unidrive S III ARTHRO with SCB
• 04048551253663: UNIDRIVE® S III ECO
• 04048551253656: KARL STORZ UNIDRIVE® S III ENT with SCB
• 04048551071601: Unidrive ENT with SCB
• 04048551071571: UNIDRIVE® ECO
• 04048551071557: UNIDRIVE® GYN with KARL STORZ-SCB