AccessGUDID - DEVICE: Epredia (00673693089869)

GUDID

Device Identifier (DI) Information

Brand Name: Epredia
Version or Model: Gomori’s Trichrome Stain Green Collagen
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 88031
Company Name: RICHARD-ALLAN SCIENTIFIC COMPANY

Primary DI Number: 00673693089869
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 929504710 *Terms of Use

Device Description: Gomori’s Trichrome Stain Kit Green Collagen and its components are used as a special stain kit to distinguish between collagen and muscle fibers. The cytoplasmic stain and the collagen stain are combined into one solution along with phosphotungstic-phosphomolybdic and glacial acetic acids. Muscle cells and cytoplasm favor the red dyes, and this is facilitated by the phosphotungstic acid. Collagen fibers take up the tungstate ion, allowing for the green dye to selectively bind.

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?
43587	Biological stain IVD	A single chemical agent, dye or solution intended for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms, in a clinical specimen, for their subsequent visualization, examination, identification and/or differentiation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HYW	Stain, Trichrome, Mallory'S

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: 196b3b37-25b5-4d3c-ad70-76090bf499c6
Public Version Date: September 13, 2024
Public Version Number: 1
DI Record Publish Date: September 05, 2024