AccessGUDID - DEVICE: Epredia (00673693087025)

GUDID

Device Identifier (DI) Information

Brand Name: Epredia
Version or Model: Clear-Rite 3™
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6901
Company Name: RICHARD-ALLAN SCIENTIFIC COMPANY

Primary DI Number: 00673693087025
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 929504710 *Terms of Use

Device Description: Clear-Rite, Citrus Clearing Solvent, Xylene Substitute, Xylene, and Toluene are a group of solvents known to act as clearing reagents in the histology laboratory for tissue processing and staining. These clearing reagents are used to “clear” tissue or make it permeable to paraffin in tissue processing. In staining, Clearants are used after alcohol which dehydrates the tissue to enable the slide to be cover slipped with a resinous mounting media.

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):	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?
59122	Xylene solution substitute IVD	A xylene substitute solution which may include d-limonene and/or hydrocarbon-based solutions, intended to be used alone or in combination with other IVDs in the processing, staining and/or testing of clinical laboratory specimens.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KEM	Agent, Clearing

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: a6efd661-1fb3-4acb-9b80-640f7097d6e6
Public Version Date: July 30, 2024
Public Version Number: 1
DI Record Publish Date: July 22, 2024