LAM Fixation Carotid surgery 3998

GUDID 04260493311014

LAM Set Carotid surgery WITHOUT probes, bilateral, screw topped

Compumedics Germany GmbH

Noninvasive vascular ultrasound system probe

• Primary Device ID: 04260493311014
• NIH Device Record Key: 14b0c422-a207-4d94-a6ec-bf0fb434e769
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LAM Fixation Carotid surgery
• Version Model Number: Fix_LAM_C_3998
• Catalog Number: 3998
• Company DUNS: 344791632
• Company Name: Compumedics Germany GmbH
• 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: false
• 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: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de
• Phone: +497731797690
• Email: info@dwl.de

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260493311014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051085

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

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: 2020-12-17
• Device Publish Date: 2020-12-09

On-Brand Devices [LAM Fixation Carotid surgery]

• 04260493311946: LAM Set Carotid surgery bilateral with 2 x 1 MHz probe, click&stay
• 04260493311939: LAM Set Carotid surgery bilateral with 2 x 1 MHz probe, screw topped
• 04260493311922: LAM Set Carotid surgery unilateral with 1 MHz probe, click&stay
• 04260493311915: LAM Set Carotid surgery unilateral with 1 MHz monitoring probe, screw topped
• 04260493311496: LAM Set Carotid surgery bilateral with 2 x 2 MHz probe, click&stay
• 04260493311489: LAM Set Carotid surgery bilateral with 2 x 2 MHz probe, screw topped
• 04260493311472: LAM Set Carotid surgery unilateral with 2 MHz probe, click&stay
• 04260493311465: LAM Set Carotid surgery unilateral with 2 MHz monitoring probe, screw topped
• 04260493311014: LAM Set Carotid surgery WITHOUT probes, bilateral, screw topped