AccessGUDID - DEVICE: Methyl Green Counterstainer (B502BSB01250)

GUDID

Device Identifier (DI) Information

Brand Name: Methyl Green Counterstainer
Version or Model: 200 ml
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BSB 0125
Company Name: BIO SB, INC.

Primary DI Number: B502BSB01250
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 102855447 *Terms of Use

Device Description: Methyl Green Counterstainer is used as a counterstainer with chromogens that tolerate dehydration and permanent mounting.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
43587	Biological stain IVD	A single chemical agent, dye or solution intended for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms, in a clinical specimen, for their subsequent visualization, examination, identification and/or differentiation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PPM	General Purpose Reagent

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: f1283db7-23ff-4d0a-857d-f8304e8c7493
Public Version Date: October 08, 2020
Public Version Number: 1
DI Record Publish Date: September 30, 2020