AccessGUDID - DEVICE: XyGreen PermaMounter (B502BSB01690)

GUDID

Device Identifier (DI) Information

Brand Name: XyGreen PermaMounter
Version or Model: 15 ml
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BSB 0169
Company Name: BIO SB, INC.

Primary DI Number: B502BSB01690
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 102855447 *Terms of Use

Device Description: XyGreen PermaMounter is a non-toxic, biodegradable permanent mounting media used for the preservation of immunohistochemical and CISH stainings. XyGreen for mounting cells or tissue sections

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?
43550	Microscopy mounting medium IVD	A substance intended to be used to create a seal between a microscope slide, clinical specimen and/or coverslip, to preserve the specimen and/or the integrity of any dye(s) used for staining, and enhance image quality during microscopic examination.	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: b0676be2-400c-4d23-9f83-b394bea83f1e
Public Version Date: July 25, 2024
Public Version Number: 2
DI Record Publish Date: September 30, 2020