AccessGUDID - DEVICE: ClaraMount™ Coverslip mounting medium (00860012688937)

GUDID

Device Identifier (DI) Information

Brand Name: ClaraMount™ Coverslip mounting medium
Version or Model: 900-00023
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Clarapath, Inc.

Primary DI Number: 00860012688937
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079469240 *Terms of Use

Device Description: For use as a permanent, resin based mounting medium in histological preparations on slides produced by SectionStar™

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:	Yes
Prescription Use (Rx):	Yes
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
LEB	Mounting Media

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: 19995e56-c2b1-4755-84e6-43f0986e7ca4
Public Version Date: September 02, 2024
Public Version Number: 1
DI Record Publish Date: August 23, 2024