AccessGUDID - DEVICE: Key Surgical Endoscope Brushes (00849771040637)

GUDID

Device Identifier (DI) Information

Brand Name: Key Surgical Endoscope Brushes
Version or Model: EB10105
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: EB10105
Company Name: KEY SURGICAL, INC.

Primary DI Number: 00849771040637
Issuing Agency: GS1
Commercial Distribution End Date: July 24, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 604056226 *Terms of Use

Device Description: Endoscope Brush, Double-Ended, Pipe Cleaner, 2300mm L, 5mm Diam, 125mm BAL, 5mm Diam, 20mm BAL

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):	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?
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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1c533c8a-47e2-44ca-b33e-08c2df135f0e
Public Version Date: July 25, 2023
Public Version Number: 5
DI Record Publish Date: January 31, 2020