AccessGUDID - DEVICE: Universal Adapter 5-10mm (04589698450459)

GUDID

Device Identifier (DI) Information

Brand Name: Universal Adapter 5-10mm
Version or Model: PS-SU-040
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MITAKA KOHKI CO., LTD.

Primary DI Number: 04589698450459
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 692666613 *Terms of Use

Device Description: This device is designed to be used with the endoscope holder "Point Setter" manufactured by Mitaka Kohki Co., Ltd.

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):	No
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?
62380	Surgical instrument assist arm system, power-adjusted	A device assembly adjusted or stabilized by electrical, electro-pneumatic or pneumatic means, 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
GWG	Endoscope, Neurological
GCJ	Laparoscope, General & Plastic Surgery

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 [?]
Moist Heat or Steam Sterilization
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: 6fd8cdc9-fa69-4e1f-9a7d-5001e67fbeb5
Public Version Date: March 11, 2019
Public Version Number: 1
DI Record Publish Date: February 06, 2019