AccessGUDID - DEVICE: Laryngostroboscope (00848657070218)

GUDID

Device Identifier (DI) Information

Brand Name: Laryngostroboscope
Version or Model: 8000-S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8000-S
Company Name: NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

Primary DI Number: 00848657070218
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 839138955 *Terms of Use

Device Description: Laryngostroboscopes employ the oscillating light of a high-power fluorescent light source that is monitored by the laryngeal vibrations through a throat microphone.

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):	Yes
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?
15076	Rigid intubation laryngoscope, reusable	A hand-held device intended to be used by anaesthesia/emergency service personnel to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. It has a handle containing batteries to power its light (a small built-in light bulb or fibreoptic light) for airway illumination, and a curved or straight blade of various designs and lengths that can be hinged/interchanged or integral. Some types can be magnetic resonance imaging (MRI) compatible. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
EQL	Laryngostroboscope

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 1914e729-3e17-4586-980f-03f899718e01
Public Version Date: October 20, 2023
Public Version Number: 1
DI Record Publish Date: October 12, 2023