AccessGUDID - DEVICE: PENTAX (04961333224258)

GUDID

Device Identifier (DI) Information

Brand Name: PENTAX
Version or Model: FNL-10RP3
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HOYA CORPORATION

Primary DI Number: 04961333224258
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 691519705 *Terms of Use

Device Description: Perform cleaning, high-level disinfection, and/or sterilization according to the procedure specified in the Instructions for Use (Reprocessing) of this instrument.

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 [?]
K951196	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: d3b1c35d-88fa-4d0c-b0d9-88d9c381e296
Public Version Date: September 27, 2018
Public Version Number: 4
DI Record Publish Date: April 07, 2017