AccessGUDID - DEVICE: HOLDER FOR HC-RP (04953170305849)

GUDID

Device Identifier (DI) Information

Brand Name: HOLDER FOR HC-RP
Version or Model: MAJ-1938
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N3807700
Company Name: OLYMPUS MEDICAL SYSTEMS CORP.

Primary DI Number: 04953170305849
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 711789789 *Terms of Use

Device Description: MAJ-1938 ScopeGuide Holder for HC-RC

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?
43266	Sensor holder, reusable	A device designed to hold (house) a sensor so that it is fixed (locked) in a stable position. This device will then allow for the holder and the attached sensor to be fastened to, e.g., the patient's body during computer assisted surgery (CAS), another device, or a suitable place in the vicinity of use. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FDF	Colonoscope and accessories, flexible/rigid
FDA	Enteroscope And Accessories
PGU	Spatial Imaging For Display Of Endoscope Position

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: aaf95c06-84e0-4f5b-9186-562928ac7a93
Public Version Date: December 27, 2023
Public Version Number: 6
DI Record Publish Date: September 21, 2016