AccessGUDID - DEVICE: Epredia (00673693202244)

GUDID

Device Identifier (DI) Information

Brand Name: Epredia
Version or Model: Oxalic Acid Solution (1%)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 88045
Company Name: RICHARD-ALLAN SCIENTIFIC COMPANY

Primary DI Number: 00673693202244
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 929504710 *Terms of Use

Device Description: Potassium Permanganate Solution is the oxidizing agent in this technique. It is followed by an Oxalic Acid Solution to remove the excess permanganate. This step serves to enhance the subsequent staining of the reticular fibers. A sensitizing step using Ferric Ammonium Sulfate Solution impregnates the fibers, creating a metal-organic bond that is replaced by silver during subsequent treatment with Working Ammoniacal Silver Solution. To develop the visible silver, a Reducing Solution of dilute formaldehyde is used. The tissue structures that have been impregnated with the silver solution will now appear brown to black. Gold Chloride Solution is used to “tone” the sections, producing better contrast and clarity as the gold reacts and combines with the reduced silver. Unreduced silver is removed via treatment with Sodium Thiosulfate Solution. An optional nuclear fast red counterstain provides background staining as well as nuclear detail.

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
LED	Stains, Chemical 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: dc02f1d8-9333-443f-8926-d4c6a976c122
Public Version Date: September 16, 2024
Public Version Number: 1
DI Record Publish Date: September 06, 2024