AccessGUDID - DEVICE: Epredia (00673693088961)

GUDID

Device Identifier (DI) Information

Brand Name: Epredia
Version or Model: Cytoseal™ 280
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8311-4
Company Name: RICHARD-ALLAN SCIENTIFIC COMPANY

Primary DI Number: 00673693088961
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 929504710 *Terms of Use

Device Description: Cytoseal™ 280 is a toluene-based mounting medium formulated from acrylic resins and will not crack or discolor with age. The addition of antioxidants inhibits fading or yellowing of stained specimens. This is a high-viscosity medium for applications where minimal spreading is desired.

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?
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: 4591f266-3a38-4b03-aaf0-552670ab2936
Public Version Date: August 07, 2024
Public Version Number: 1
DI Record Publish Date: July 30, 2024