AccessGUDID - DEVICE: Epredia (00673693203845)

GUDID

Device Identifier (DI) Information

Brand Name: Epredia
Version or Model: ParaPel
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2300
Company Name: RICHARD-ALLAN SCIENTIFIC COMPANY

Primary DI Number: 00673693203845
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 929504710 *Terms of Use

Device Description: ParaPel is designed to be used at full strength and does not require any additives. It is used as a paraffin repellent for countertops, microtomes and microtome accessories.

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?
64424	Paraffin anti-adhesion agent IVD	A fluid substance (e.g., in a spray container) intended to be applied to the surface of laboratory working fixtures and equipment (e.g., countertop, microtome) to prevent the adherence of paraffin wax, or applied to the surface of tissue embedding moulds prior to the embedding procedure to facilitate release of the paraffin block, typically during pathology specimen preparation. After application, this device cannot be reused.	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: e91721e1-525f-47d9-9693-52bf1cd2bc12
Public Version Date: August 07, 2024
Public Version Number: 1
DI Record Publish Date: July 30, 2024