VERSACRANE

GUDID 04048551337400

VERSACRANE Holding Arm, high, mobile

Karl Storz GmbH & Co. KG

Surgical instrument assist arm system, manually-adjusted

• Primary Device ID: 04048551337400
• NIH Device Record Key: 9ce844ca-a4c5-4152-a815-8b79f1cd6b02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VERSACRANE
• Version Model Number: 28272HS
• 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	04048551337400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K951535

FDA Product Code

• OCV: Endoscope holder

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-04-09
• Device Publish Date: 2018-08-21

On-Brand Devices [VERSACRANE]

• 04048551337400: VERSACRANE Holding Arm, high, mobile
• 04048551321560: VERSACRANE Holding Arm, low