AccessGUDID - DEVICE: INFRARED AND BLUE LIGHT FILTER UNIT (04953170396113)

GUDID

Device Identifier (DI) Information

Brand Name: INFRARED AND BLUE LIGHT FILTER UNIT
Version or Model: MAJ-2308
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N5769940
Company Name: OLYMPUS MEDICAL SYSTEMS CORP.

Primary DI Number: 04953170396113
Issuing Agency: GS1
Commercial Distribution End Date:
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):	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?
64399	Surgical microscope video camera filter switch	A switching component of a surgical microscope video camera intended to facilitate either the application of a single light wavelength filter or the changing from one filter to another. The filters are incorporated within the main microscope assembly and are typically infrared and/or blue. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IZI	System, X-Ray, Angiographic
EPT	Microscope, Surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K190772	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: 261b14c0-cd5e-4fc7-a162-3e9f50c829e3
Public Version Date: April 22, 2024
Public Version Number: 3
DI Record Publish Date: July 25, 2022