AccessGUDID - DEVICE: Slide Label Roll (8,000) labels (B502BSB74510)

GUDID

Device Identifier (DI) Information

Brand Name: Slide Label Roll (8,000) labels
Version or Model: BSB-7451
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BSB-7451
Company Name: BIO SB, INC.

Primary DI Number: B502BSB74510
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?
63375	Printer label IVD	A thin, blank sheet of fibrous material, typically with an adhesive underside, intended to be imprinted with an image/text using a printer, and then applied to an object for identification (e.g., barcode) or information associated with an in vitro diagnostic procedure. It is typically available as a continuous roll with individual labels arranged on a waxy backing sheet for easy peeling. 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: 1f9e39cc-4a05-45df-bef8-836a29e6d395
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