AccessGUDID - DEVICE: RHINO-LARYNGO VIDEOSCOPE (04953170310416)

GUDID

Device Identifier (DI) Information

Brand Name: RHINO-LARYNGO VIDEOSCOPE
Version or Model: OLYMPUS ENF-V3
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: N3828230
Company Name: OLYMPUS MEDICAL SYSTEMS CORP.

Primary DI Number: 04953170310416
Issuing Agency: GS1
Commercial Distribution End Date: January 11, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 711789789 *Terms of Use

Device Description: ENF-V3 Flexible ultra thin video Rhino L

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?
35462	Flexible video laryngoscope	An endoscope with a flexible inserted portion intended for the visual examination and treatment of the larynx. It is inserted into the body through the mouth during laryngoscopy. Anatomical images are transmitted to the user by a video system at the distal end of the endoscope with the images showing on a monitor. This device is commonly used to evaluate or operate on laryngeal strictures, foreign bodies, or neoplasms; it is not intended for intubation of an artificial airway. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EOB	NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)
NWB	Endoscope, accessories, narrow band spectrum

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K221638	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
High-level Disinfectant
Ethylene Oxide

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: db42aa98-efcf-4df9-82e5-ee68f3b3c9bb
Public Version Date: April 22, 2024
Public Version Number: 7
DI Record Publish Date: September 21, 2016