AccessGUDID - DEVICE: ClaraCut™ Blades (00860012688913)

GUDID

Device Identifier (DI) Information

Brand Name: ClaraCut™ Blades
Version or Model: 900-00022
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Clarapath, Inc.

Primary DI Number: 00860012688913
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079469240 *Terms of Use

Device Description: Microtome blade cartridge for use in SectionStar™ auto-sectioning machine for the preparation of pathology specimens. Microtome blades are used for sectioning a variety of sample types, including fixed, paraffin embedded cell and tissue blocks.

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):	Yes
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: d5e332fa-7bd3-484c-ab32-a0abb4d9d3a4
Public Version Date: September 02, 2024
Public Version Number: 1
DI Record Publish Date: August 23, 2024