AccessGUDID - DEVICE: Epredia (00673693227506)

GUDID

Device Identifier (DI) Information

Brand Name: Epredia
Version or Model: Stainless Steel Base Molds
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6401015
Company Name: RICHARD-ALLAN SCIENTIFIC COMPANY

Primary DI Number: 00673693227506
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 929504710 *Terms of Use

Device Description: Stainless-steel base molds are made of high-quality, durable stainless-steel fitting most cassettes with superior thermal exchange and round corners. Stainless-steel base molds can be cleaned with xylene or a paraffin repellant for continued use. Stainless-steel base molds come in four different sizes to accommodate different tissue sizes.

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:	No
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?
63792	Tissue embedding mould IVD, reusable	A metal container of square or rectangular shape intended to be used to embed tissue specimens into an embedding medium (e.g., paraffin wax) to form a solid block, which is subsequently cut into thin sections for processing and analysis of the tissue specimen. It is typically made of stainless steel. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KER	Container, Embedding

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: 91c5726d-ace4-4eb8-800d-8e20d8db3fc0
Public Version Date: October 16, 2024
Public Version Number: 1
DI Record Publish Date: October 08, 2024