AccessGUDID - DEVICE: Epredia (00673693228435)

GUDID

Device Identifier (DI) Information

Brand Name: Epredia
Version or Model: Gill 1 Hematoxylin (Series S)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6765005
Company Name: RICHARD-ALLAN SCIENTIFIC COMPANY

Primary DI Number: 00673693228435
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 929504710 *Terms of Use

Device Description: Gill Hematoxylin 1, 2, and 3 are rapid, progressive hematoxylins that are widely known and respected in the histology and cytology fields. They offer convenience and choice of stain intensity. Gill hematoxylins are ready to use and will provide familiar, consistent, well-delineated results. Stain filtering may be needed to remove sheen caused by oxidation or cells shed off of slides in the cytology staining process. Gill 1 is the least intense stain and is most commonly used in cytology and in special stains. Gill 2 is a moderately intense stain and is most commonly used in histology, with some limited use in cytology. Gill 3 is an intense stain and is exclusively used in histology as well as staining of plastic sections.

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
HYJ	Hematoxylin

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: e212570f-770f-46bd-84b8-02aceeb966c0
Public Version Date: September 11, 2024
Public Version Number: 1
DI Record Publish Date: September 03, 2024