AccessGUDID - DEVICE: Slide Label Printing Ribbon (B502BSB74520)

GUDID

Device Identifier (DI) Information

Brand Name: Slide Label Printing Ribbon
Version or Model: BSB-7452
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BSB-7452
Company Name: BIO SB, INC.

Primary DI Number: B502BSB74520
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?
62926	Microscope slide labelling cartridge IVD	A device designed to be inserted into an automated microscope slide processing instrument (e.g., printer, stainer, or maker) to label a microscope slide for specimen identification prior to blood smearing. It is a casing, similar to a paper printer cartridge, with a printer ribbon that makes thermal contact with the slide, with heat and printed data from the processing instrument, to transfer information to the slide.	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: eb83bd68-e96d-4e2b-8b2e-321f2a6c5de6
Public Version Date: March 26, 2025
Public Version Number: 1
DI Record Publish Date: March 18, 2025

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)561-1145
Email: sales@biosb.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES