AccessGUDID - DEVICE: Epredia (00673693181938)

GUDID

Device Identifier (DI) Information

Brand Name: Epredia
Version or Model: Mark-It™ Tissue Marking Yellow
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5000Y
Company Name: RICHARD-ALLAN SCIENTIFIC COMPANY

Primary DI Number: 00673693181938
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 929504710 *Terms of Use

Device Description: Tissue Marking Dyes are intended as an aid in the orientation, of excised surgical specimens through frozen sectioning, processing, and sectioning, and subsequent microscopic examination of tissues. The marking of multiple margins with these dyes is especially useful for identification in skin biopsies, a technique known as Moh’s surgery. These dyes are normally applied to fresh tissue but may also be used with fixed tissue. Whether fresh or fixed, the tissue should be blotted to remove excess fluid from the surface before applying the dye. Tissue Marking Dyes will permanently bond to the tissue 1 to 2 minutes after application. The tissue can then be frozen and prepared for sectioning or placed in formalin or other fixatives and processed for paraffin embedding.

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?
63615	Biopsy tissue marking dye kit IVD	A coloured solution intended to be used to permanently mark the surgical margins and/or other general areas of interest on a tissue biopsy specimen; it is not intended to stain a tissue section for the visualization of intra/extracellular elements. It is one of a set, or a set of multiple colours (e.g., red, blue, black, green, violet and/or orange) which can withstand tissue processing (e.g., tissue fixation, freezing) without fading or bleeding. Applicators for precise marking or spreading of the dye onto the tissue specimen may be included.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LEE	Stains, Dye Solution

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: 191d98e9-69d4-4008-b5d8-8401ed2448e7
Public Version Date: August 14, 2024
Public Version Number: 1
DI Record Publish Date: August 06, 2024