AccessGUDID - DEVICE: ARM CLAMP 2 (04953170062490)

GUDID

Device Identifier (DI) Information

Brand Name: ARM CLAMP 2
Version or Model: MAJ-851
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 6798200
Company Name: OLYMPUS MEDICAL SYSTEMS CORP.

Primary DI Number: 04953170062490
Issuing Agency: GS1
Commercial Distribution End Date: July 09, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 711789789 *Terms of Use

Device Description: "MAJ-851 WM-30/60 & MAJ-683 arm clamp"

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?
62379	Surgical instrument assist arm system, manually-adjusted	A manually-powered/-adjusted device assembly intended to be used to hold, maintain in a desired position, and enable positional adjustment of surgical and/or endoscopic instruments during an endoscopic examination/surgical procedure (i.e., during use). It typically consists of rigid or semi-rigid arms with joints, instrument holding and locking mechanisms, and a clamping mechanism for fixation to a stable object (e.g., the operating table) or is mounted on a mobile (on wheels) base.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FEM	Accessories, Photographic, For Endoscope (Exclude Light Sources)

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: c808d159-84cc-4181-8129-f147868eb73f
Public Version Date: July 10, 2024
Public Version Number: 6
DI Record Publish Date: September 21, 2016