AccessGUDID - DEVICE: TintoAutomation Probe Cleaner Kit (B502BSB74630)

GUDID

Device Identifier (DI) Information

Brand Name: TintoAutomation Probe Cleaner Kit
Version or Model: BSB-7463
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BSB-7463
Company Name: BIO SB, INC.

Primary DI Number: B502BSB74630
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 102855447 *Terms of Use

Device Description: The TintoAutomation Cleaner is a 3-component cleaning solution for removal of DAB chromogen stains and precipitates from the TintoStainer Plus automated platform, glassware, labware, or other surfaces that come in contact with DAB.

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:	No
Prescription Use (Rx):	No
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?
33543	Microscope slide tray	A device designed to safely store and organize stained microscope slides for their protection and presentation. This device is available as flat tray made of plastic materials in which the slides are placed flat into recesses. It will typically be made of white material to provide a background that facilitates slide viewing. This device will typically be placed in a microscope slide storage cabinet. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXG	EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE

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: d3124c22-ebfb-4918-a395-e85a87300b88
Public Version Date: March 26, 2025
Public Version Number: 1
DI Record Publish Date: March 18, 2025