AccessGUDID - DEVICE: IntraVu Scope 60 (00865351000365)

GUDID

Device Identifier (DI) Information

Brand Name: IntraVu Scope 60
Version or Model: IV-ASY-1060
Commercial Distribution Status: In Commercial Distribution
Catalog Number: IV-ASY-1060
Company Name: INTRAVU, INC.

Primary DI Number: 00865351000365
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 116708692 *Terms of Use

Device Description: Kit containing 60mm Scope and 60mm Cannula, 60mm Trocar, and Stopcock. IntraVu Scope is a miniaturized, sterile, single-use, disposable scope for use with the IntraVu Tablet reusable video processing unit.

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
62570	Rigid optical arthroscope, single-use	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, temporomandibular joint (TMJ)]. 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 eyepiece is normally interfaced with a video camera. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HRX	Arthroscope
GCJ	Laparoscope, General & Plastic Surgery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K181982	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 15 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -18 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 60 Millimeter

Device Record Status

Public Device Record Key: af6dde3f-c232-4deb-9ee6-daffeeac1cdd
Public Version Date: November 17, 2023
Public Version Number: 2
DI Record Publish Date: December 02, 2019