AccessGUDID - DEVICE: AccuThrive® (00843382104078)

GUDID

Device Identifier (DI) Information

Brand Name: AccuThrive®
Version or Model: Microtome Blade
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AVBL-2020-0000
Company Name: AccuTec, Inc.

Primary DI Number: 00843382104078
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079966794 *Terms of Use

Device Description: AccuThrive Vitality Microtome Blade High Profile SS Microcoat 100BL/CA (10BL/DISP 10DISP/CA)

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?
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: 9e3298bf-af2d-4d1e-9f52-d43fc7b369f5
Public Version Date: December 25, 2024
Public Version Number: 1
DI Record Publish Date: December 17, 2024