AccessGUDID - DEVICE: Revital-Ox (00724995002053)

GUDID

Device Identifier (DI) Information

Brand Name: Revital-Ox
Version or Model: 2D77QH
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 2D77QH
Company Name: US Endoscopy

Primary DI Number: 00724995002053
Issuing Agency: GS1
Commercial Distribution End Date: July 01, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 627879687 *Terms of Use

Device Description: Revital-Ox All-In-One Channel and Valve Control Brush support effective cleaning inside lumened instruments with the control of a flexible stainless steel handle delivering control while gentle nylon bristles dislodge bioburden from hard to reach interior channels.

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:	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?
38835	Surgical instrument/endoscope cleaning utensil, single-use	A non-absorbent, non-powered, hand-held device in the form of a brush, a wire, strip of metal, or handle intended to clean the exterior and/or interior (lumen) of a surgical instrument (e.g., bur, reamer, bone tap, suturing device, sheath/shaft, ultrasonic surgical handpiece) and/or endoscope. The bristles, fibres or spines of brushes may be mounted along a single plane or radiate out around a central shaft, and may be soft or stiff; the shaft/handle of brushes may be flexible or rigid. The device may be used to clean endoscopic or open-surgery instruments, and it may have a handle or a connector/adaptor at the proximal end. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MNL	ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE

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
Special Storage Condition, Specify: Keep Dry

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3bcec852-9cf8-4a04-89a7-e4d7c0297dbb
Public Version Date: July 02, 2024
Public Version Number: 3
DI Record Publish Date: March 31, 2021