AccessGUDID - DEVICE: ENDOSCOPE POSITION DETECTING UNIT (04953170331145)

GUDID

Device Identifier (DI) Information

Brand Name: ENDOSCOPE POSITION DETECTING UNIT
Version or Model: UPD-3
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: OLYMPUS MEDICAL SYSTEMS CORP.

Primary DI Number: 04953170331145
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:	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?
44924	Gastrointestinal catheter/endoscope tracking system	A multicomponent assembly of mains electricity (AC-powered) devices designed for real-time visualization/navigation of a catheter and/or endoscope during insertion in the gastrointestinal tract, by detecting its position/movement within an electromagnetic (EM) field and displaying three-dimensional (3-D) virtual images on a monitoring screen. The system primarily consists of a main control unit with monitor and an external EM field generator or sensor, and may also require/include an external reference sensor; additional accessories (e.g., remote control, stand/trolley) may also be included.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FDA	Enteroscope and accessories
PGU	Spatial imaging for display of endoscope position
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: 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: 9dda5222-cd99-442a-bc1c-84a33a6cfad5
Public Version Date: January 16, 2023
Public Version Number: 6
DI Record Publish Date: September 21, 2016