AccessGUDID - DEVICE: RHINO-LARYNGOFIBERSCOPE (04953170318214)

GUDID

Device Identifier (DI) Information

Brand Name: RHINO-LARYNGOFIBERSCOPE
Version or Model: OLYMPUS ENF-T3
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: OLYMPUS MEDICAL SYSTEMS CORP.

Primary DI Number: 04953170318214
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: No description.

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?
44715	Flexible fibreoptic nasopharyngolaryngoscope	An endoscope with a flexible inserted portion intended for the visual examination and treatment of the structures inside the nasal passages, including the sinus openings, the pharyngeal end of the auditory tube, the larynx, and the vocal cords. It is inserted through a nostril and typically provides the operator with greater manoeuvrability (flexibility of the distal end) for improved viewing during nasopharyngolaryngoscopy. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EOB	Nasopharyngoscope (flexible or rigid)

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Ethylene Oxide
High-level Disinfectant

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: 955678c6-fc96-448e-9be5-08b3e89e8380
Public Version Date: January 12, 2024
Public Version Number: 6
DI Record Publish Date: October 06, 2017