AccessGUDID - DEVICE: TintoCoverslips: 24mm x 24mm : 100 Precleaned Slides (B502BSB71001000)

GUDID

Device Identifier (DI) Information

Brand Name: TintoCoverslips: 24mm x 24mm : 100 Precleaned Slides
Version or Model: BSB-7100-100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BSB-7100-100
Company Name: BIO SB, INC.

Primary DI Number: B502BSB71001000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 102855447 *Terms of Use

Device Description: Accessory of the Tinto Stainer Plus Automated System

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:	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?
15687	Microscope slide coverslip IVD	A thin piece of glass or a plastic sheath placed over a specimen on a microscope slide, to serve as a physical barrier to protect the specimen from mechanical forces and environmental exposure. This is a single-use 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: 13cc11cb-cd29-4ace-b58a-e2f9cd9afcb5
Public Version Date: March 26, 2025
Public Version Number: 1
DI Record Publish Date: March 18, 2025