AccessGUDID - DEVICE: Rowley Biochemical Modified Orange G (M8015852042008)

GUDID

Device Identifier (DI) Information

Brand Name: Rowley Biochemical Modified Orange G
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M-801-5
Company Name: TRANSENE COMPANY, INC.

Primary DI Number: M8015852042008
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 044815983 *Terms of Use

Device Description: Modified Orange G Solution for Papanicolau Staining

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:	No
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
HZJ	Stain, Papanicolau

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
Total Volume: 1 Gallon
Total Volume: 1 Quart
Total Volume: 1 Pint
Total Volume: 8 Fluid Ounce
Total Volume: 4 Fluid Ounce

Device Record Status

Public Device Record Key: b27eb02d-ef68-445a-bd89-bafaeeb2fcd0
Public Version Date: September 23, 2019
Public Version Number: 1
DI Record Publish Date: September 13, 2019