AccessGUDID - DEVICE: Epredia (00673693089944)

GUDID

Device Identifier (DI) Information

Brand Name: Epredia
Version or Model: Hydroquinone Capsules
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 88035
Company Name: RICHARD-ALLAN SCIENTIFIC COMPANY

Primary DI Number: 00673693089944
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 929504710 *Terms of Use

Device Description: Modified Steiner-Steiner Silver Stain Kit aids in identifying spirochetes and non-filamentous bacteria in tissue sections for the diagnosis of general pathology specimens. Microorganisms that stain positively with this technique have a cell wall that will adsorb silver from a silver solution (argyrophilic). The silver is first adsorbed in a non-visible form and is subsequently reduced by the Working Reducing Solution (hydroquinone) to a visible metallic silver.

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: e6c5c5ef-d01f-4800-b713-f756671b6f46
Public Version Date: September 16, 2024
Public Version Number: 1
DI Record Publish Date: September 06, 2024