AccessGUDID - DEVICE: BLUE LIGHT IMAGING UNIT (04953170396021)

GUDID

Device Identifier (DI) Information

Brand Name: BLUE LIGHT IMAGING UNIT
Version or Model: MAJ-2305
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N5769640
Company Name: OLYMPUS MEDICAL SYSTEMS CORP.

Primary DI Number: 04953170396021
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?
58474	Software upgrade/unlocking key	A software, hardware, or software/hardware combination device intended to be used to update/upgrade/unlock software embedded on a medical device through the use of an integral or separate media device (e.g., USB flash drive, CD). If supplied on a dedicated USB drive, it may be otherwise known as a ‘dongle’. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EPT	Microscope, Surgical

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: 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: 192a5ea0-1e1a-4aa6-9fc2-faf276bbf5f0
Public Version Date: August 02, 2022
Public Version Number: 1
DI Record Publish Date: July 25, 2022