AccessGUDID - DEVICE: ClaraTape™ Transfer Tape (00860012688906)

GUDID

Device Identifier (DI) Information

Brand Name: ClaraTape™ Transfer Tape
Version or Model: 900-00020
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Clarapath, Inc.

Primary DI Number: 00860012688906
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079469240 *Terms of Use

Device Description: Clarapath tape is intended to assist in the cutting and transfer of tissue sections in SectionStar™ auto-sectioning machine

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?
15158	Rotary microtome IVD	A precision cutting instrument intended to be used to cut tissue sections, fixed in paraffin wax, into thin slices for subsequent in vitro diagnostic analysis. The device has a vertically-fixed knife which cuts through the paraffin block vertically, and a flywheel mechanism which cuts sections with each turn.	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: 15d83232-8999-49d5-ada2-baf325e479a6
Public Version Date: September 02, 2024
Public Version Number: 1
DI Record Publish Date: August 23, 2024