FlexGuard

GUDID 14250341911579

Insertion sheath for laser fibres to protect the inner lining of the working channel of an endoskope.

LISA Laser Products GmbH

Laser lithotripsy fibre/suction guide

• Primary Device ID: 14250341911579
• NIH Device Record Key: 4d439831-d580-4f81-8ebb-e08df9474729
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FlexGuard
• Version Model Number: 101 503 631
• Company DUNS: 315026396
• Company Name: LISA Laser Products 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +49555699380
• Email: info@lisalaser.de

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250341911572 [Primary]
GS1	14250341911579 [Package]; Contains: 04250341911572; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070924

FDA Product Code

• FED: Endoscopic Access Overtube, Gastroenterology-Urology

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-22
• Device Publish Date: 2018-09-21

Devices Manufactured by LISA Laser Products GmbH

• 04250341911695 - RevoLix HTL: 2024-04-12 The RevoLix HTL laser device is a Thulium-YAG laser and emits radiation of the wavelength 2013 nm (±10 nm) (equivalent to appro
• 14250341911579 - FlexGuard: 2018-10-22Insertion sheath for laser fibres to protect the inner lining of the working channel of an endoskope.
• 14250341911579 - FlexGuard: 2018-10-22 Insertion sheath for laser fibres to protect the inner lining of the working channel of an endoskope.