AccessGUDID - DEVICE: Laryngoskop FS2 (B809M105220300700)

GUDID

Device Identifier (DI) Information

Brand Name: Laryngoskop FS2
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: orlvision GmbH

Primary DI Number: B809M105220300700
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 341467978 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45043	Flexible video nasopharyngoscope	An endoscope with a flexible inserted portion intended for the visual examination and treatment of the nasopharynx (the upper part of the throat behind the nose). It is inserted through a nostril during ear/nose/throat (ENT) procedures. Anatomical images are transmitted to the user by a video system with a charge-coupled device (CCD) chip at the distal end of the endoscope and the images showing on a monitor. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EQN	Laryngoscope, Nasopharyngoscope

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K150248	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9e034905-89b0-4974-b931-5d834f662cca
Public Version Date: October 27, 2020
Public Version Number: 1
DI Record Publish Date: October 19, 2020