AccessGUDID - DEVICE: ENDOSCOPE POSITION MARKING PROBE (04953170353406)

GUDID

Device Identifier (DI) Information

Brand Name: ENDOSCOPE POSITION MARKING PROBE
Version or Model: MAJ-1878
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OLYMPUS MEDICAL SYSTEMS CORP.

Primary DI Number: 04953170353406
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 711789789 *Terms of Use

Device Description: MAJ-1878 SCOPEGUIDE PROBE 2.8MM

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?
64659	Electromagnetic endoscope tracking system reference transmitter, internal	A long, flexible, invasive component of an electromagnetic (EM) endoscope tracking system intended for insertion into one of the channels (e.g., biopsy channel) of an appropriate in situ endoscope, and designed to emit EM pulses for locating/tracking the endoscope. It is intended to be used with endoscopes which do not have integrated EM pulse-generating tracking technology. The EM field/pulses generated by this device are received by external sensors. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PGU	Spatial imaging for display of endoscope position
FDA	Enteroscope and accessories
FDF	Colonoscope and accessories, flexible/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 [?]
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: a2e21c8e-5fa7-4363-94ea-7756fe27e14c
Public Version Date: January 16, 2023
Public Version Number: 6
DI Record Publish Date: September 21, 2016