AccessGUDID - DEVICE: Epredia (00673693248631)

GUDID

Device Identifier (DI) Information

Brand Name: Epredia
Version or Model: CytoRich Red Collection Fluid
Commercial Distribution Status: In Commercial Distribution
Catalog Number: B9990800
Company Name: RICHARD-ALLAN SCIENTIFIC COMPANY

Primary DI Number: 00673693248631
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 929504710 *Terms of Use

Device Description: Fixation is vital in the stabilization and maintenance of the existing form and structure of all cellular constituents. The fixative, when applied, coats, and protects cells with a water-soluble film. This film, derived from resin, coats cell preparations to preserve nuclear detail for microscopic examination and diagnosis.

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?
57752	Saccamanno solution IVD	A solution typically containing 50% ethanol and 2% polyethylene glycol (carbowax) diluted in water, intended to be used as a fixative particularly for liquid cytologic specimens such as sputum, urine, bronchial washings, and pleural and peritoneal fluids. Saccomanno solution causes lysis of red blood cells and renders uncoagulated proteins and mucus soluble for centrifugation and filtration.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LEA	Preservative, Cytological

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: 8c7804c1-515b-4403-b446-80ecc5d367ab
Public Version Date: July 29, 2024
Public Version Number: 1
DI Record Publish Date: July 19, 2024