AccessGUDID - DEVICE: Epredia (00673693221702)

GUDID

Device Identifier (DI) Information

Brand Name: Epredia
Version or Model: MX35 Premier+Microtome Blade
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3052835
Company Name: RICHARD-ALLAN SCIENTIFIC COMPANY

Primary DI Number: 00673693221702
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 929504710 *Terms of Use

Device Description: The blades and knifes consumables are for use with microtomes and cryostats. Microtomes and cryostats are devices used to produce consistent thickness slices of tissue samples, they are then mounted on glass slides, stained and typically examined by microscopy. Microtomes for light microscopy typically use disposable blades, to maintain the quality of the cut and thus the section quality. Therefore they must be changed regularly. The frequency of changing depends on the number of sections cut, hardness of the tissue and appropriate use.

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?
42440	Microtome blade IVD, single-use	A flat, wedge-shaped, sharp blade intended to be mounted into a microtome to cut micro-thin slices of tissue that has been fixed, and usually impregnated, with paraffin wax. The resulting sections are mounted onto slides for staining and then viewing with a microscope. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IDL	Microtome, Accessories

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: 5eb3266d-6571-4df5-9d30-4d756273ebaf
Public Version Date: August 09, 2024
Public Version Number: 1
DI Record Publish Date: August 01, 2024