AccessGUDID - DEVICE: Epredia (00673693180771)

GUDID

Device Identifier (DI) Information

Brand Name: Epredia
Version or Model: Neg-50™ Orange
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6502O
Company Name: RICHARD-ALLAN SCIENTIFIC COMPANY

Primary DI Number: 00673693180771
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 929504710 *Terms of Use

Device Description: Neg-50™ is formulated to yield high-quality sections even down to -50°C without chatter and is available in blue, green, orange, pink, yellow and colorless.

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?
57739	Tissue freezing/embedding medium IVD	A tissue freezing and embedding material intended to be used as an embedding matrix for the preparation and processing of frozen sections from biological tissues or clinical specimens.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KEQ	Media, Mounting, Water Soluble

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: 42b11e33-1bc0-4904-bc70-c5668927551e
Public Version Date: August 12, 2024
Public Version Number: 1
DI Record Publish Date: August 02, 2024