AccessGUDID - DEVICE: NA (10724995185548)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: Pipe Cleaner
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: PK451000
Company Name: STERIS CORPORATION

Primary DI Number: 10724995185548
Issuing Agency: GS1
Commercial Distribution End Date: September 11, 2024
Device Count: 3
Labeler D-U-N-S® Number*: 868205779 *Terms of Use

Device Description: The Cannula Cleaning Brush provides manual cleaning results for surgical instruments.

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":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
34878	Surgical instrument/endoscope cleaning utensil, reusable	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 reusable 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
Length: 2 Inch
Outer Diameter: 1 Inch

Device Record Status

Public Device Record Key: 49845d72-31af-4ace-8f0c-e1f4a80ac4da
Public Version Date: September 12, 2024
Public Version Number: 3
DI Record Publish Date: March 31, 2021