AccessGUDID - DEVICE: AnchorView Endoscope (00685447001607)

GUDID

Device Identifier (DI) Information

Brand Name: AnchorView Endoscope
Version or Model: PSZ-500-200
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Baylis Médicale Cie Inc

Primary DI Number: 00685447001607
Issuing Agency: GS1
Commercial Distribution End Date: November 16, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 249225954 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
34856	Rigid optical arthroscope, reusable	An endoscope with a rigid inserted portion intended for the visual examination and treatment of the interior of a joint (e.g., knee, shoulder, elbow). It is inserted into the body through an artificial orifice created by an incision made during arthroscopy. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. This device is typically used to examine structural damage to a joint, often from sports injuries. The arthroscope eyepiece is normally interfaced with a video camera. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HRX	Arthroscope

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

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 75 Millimeter
Lumen/Inner Diameter: 4 Millimeter
Angle: 90 degree
Device Size Text, specify: 12 deg direction of view; 30 deg field of view

Device Record Status

Public Device Record Key: 5bbf069c-e4c8-4fcc-b1d0-2a70baa483f6
Public Version Date: December 08, 2023
Public Version Number: 6
DI Record Publish Date: June 16, 2017