AccessGUDID - DEVICE: Infrared imaging unit (04953170424724)

GUDID

Device Identifier (DI) Information

Brand Name: Infrared imaging unit
Version or Model: MAJ-2304
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: OLYMPUS MEDICAL SYSTEMS CORP.

Primary DI Number: 04953170424724
Issuing Agency: GS1
Commercial Distribution End Date: August 15, 2022
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:	Yes
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
IZI	System, x-ray, angiographic

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: d7c752ff-28fd-4f92-bb22-24e74e7db4c9
Public Version Date: April 22, 2024
Public Version Number: 4
DI Record Publish Date: May 31, 2021