AccessGUDID - DEVICE: Dual Sample Chambers w/ fast,white pads,caps,48 (03661540303142)

GUDID

Device Identifier (DI) Information

Brand Name: Dual Sample Chambers w/ fast,white pads,caps,48
Version or Model: SS-213
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SS-213
Company Name: ELITECHGROUP INC.

Primary DI Number: 03661540303142
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 052423787 *Terms of Use

Device Description: Dual Sample Chambers w/ fast,white pads,caps,48

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:	Yes
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: e4b5a302-ae83-4fbb-a21b-d2f082c8aa03
Public Version Date: August 22, 2023
Public Version Number: 1
DI Record Publish Date: August 14, 2023