AccessGUDID - DEVICE: Epredia (00673693241731)

GUDID

Device Identifier (DI) Information

Brand Name: Epredia
Version or Model: TPX Sample Chamber
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A78710018
Company Name: RICHARD-ALLAN SCIENTIFIC COMPANY

Primary DI Number: 00673693241731
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 929504710 *Terms of Use

Device Description: The TPX Sample Chamber is a reusable sample chamber used in conjunction with a closure cap, Cytoclip and 2-hole disposable filter card (Brown) and (White). The Cytoclip is used to mount the Cytofunnel to the Cytospin™ Cytocentrifuge. The filter cards are designed with two cut-outs for easy insertion with the TPX chamber although only one deposition area is visualized. TPX chambers are reusable and autoclavable.

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?
63732	Cytological centrifuge funnel IVD	A small, tapered receptacle designed to be fitted into a cytological centrifuge/sample concentrator, and intended to contain and help concentrate clinical specimen suspension cells into thin-layer preparations by depositing them directly onto a microscope slide during centrifugation for subsequent examination. It is in the form of a conical-shaped plastic receptacle; some types have a slot for inserting a microscope slide. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IFB	Cytocentrifuge

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: cad39b9f-4cfd-4ecd-90bc-4594145d62a6
Public Version Date: October 28, 2024
Public Version Number: 1
DI Record Publish Date: October 18, 2024