Laryngoskop FS2

GUDID B809M105220300700

This flexible fibre scope is designed with the flexible insertion tube with its bendable distal tip, the handle with the leakage tester and connection for light source port. The handle incorporates the control lever to bend the distal tip. The picture is the region under examination is imaged by an optical unit.

orlvision GmbH

Flexible video nasopharyngoscope

• Primary Device ID: B809M105220300700
• NIH Device Record Key: 9e034905-89b0-4974-b931-5d834f662cca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Laryngoskop FS2
• Version Model Number: 1
• Company DUNS: 341467978
• Company Name: orlvision 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: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B809M105220300700 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150248

FDA Product Code

• EQN: Laryngoscope, Nasopharyngoscope

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: 2020-10-27
• Device Publish Date: 2020-10-19

Devices Manufactured by orlvision GmbH

• B809M105220300700 - Laryngoskop FS2: 2020-10-27This flexible fibre scope is designed with the flexible insertion tube with its bendable distal tip, the handle with the leakage tester and connection for light source port. The handle incorporates the control lever to bend the distal tip. The picture is the region under examination is imaged by an optical unit.
• B809M105220300700 - Laryngoskop FS2: 2020-10-27 This flexible fibre scope is designed with the flexible insertion tube with its bendable distal tip, the handle with the leakage
• B809M205220310101 - Flexible Video Rhino Laryngoscope: 2020-03-16 Flexible Video Rhino Laryngoscope, diameter flexible end 2,9 mm
• B809M205240310101 - Flexible Video Rhino Laryngoscope: 2020-03-16 Flexible Video Rhino Laryngoscope
• B809M300000003000 - Video Otoscope: 2020-03-16 Flexible Video Otoscope for examination of the outer ear
• B809M2052203101010 - Laryngoscope: 2020-03-09 Video Nasopharyngo-laryngoscope