AccessGUDID - DEVICE: Epredia (00673693089029)

GUDID

Device Identifier (DI) Information

Brand Name: Epredia
Version or Model: Paraffin, Type 9
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8337
Company Name: RICHARD-ALLAN SCIENTIFIC COMPANY

Primary DI Number: 00673693089029
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 929504710 *Terms of Use

Device Description: The Paraffin line is specially designed for tissue processing and embedding of histological and cytological specimens. The product is a white solid at room temperature and a clear, liquid when molten. The paraffin can be used with both open and closed tissue processors. It is also compatible with all embedding centers and manual embedding techniques. Paraffin is used in tissue processing during the infiltration steps. Melting points and polymer content differ between formulations. Choosing which type of paraffin may depend on the tissue density or personal preference of the histotechnician. Softer kinds of paraffin with less polymer tend to infiltrate tissue slightly quicker during processing but yield a softer block during embedding. Softer kinds of paraffin better lend themselves to thicker sections during microtomy. Harder kinds of paraffin with a higher polymer content usually take a little more time to infiltrate the tissue during processing but yield harder blocks that allow thinner sectioning during microtomy. Harder tissue specimens are better supported with a harder paraffin block.

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?
57738	Paraffin-based embedding medium IVD	A paraffin-based embedding material intended to be used as an embedding medium in the processing of biological tissues or clinical specimens.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KEO	Formulations, Paraffin, All

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: 3b37d28f-bbaf-4715-9320-4924110b08d1
Public Version Date: August 22, 2024
Public Version Number: 1
DI Record Publish Date: August 14, 2024