AccessGUDID - DEVICE: Microscope slides, 1/2G, uncoated, for Cytopro (03661540302718)

GUDID

Device Identifier (DI) Information

Brand Name: Microscope slides, 1/2G, uncoated, for Cytopro
Version or Model: SS-117
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SS-117
Company Name: ELITECHGROUP INC.

Primary DI Number: 03661540302718
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 052423787 *Terms of Use

Device Description: Microscope slides, 1/2G, uncoated, for Cytopro. Slides are used to collect the material centrifuged out of the solutions contained in the sample chambers. Slides are designed specifically for single, double, or magnum chambers and come in coated and uncoated versions for each.

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:	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?
35881	Cytological centrifuge IVD	An electrically-powered device intended to be used in a clinical laboratory setting to separate the cellular components of suspensions in a clinical specimen through centrifugal force for subsequent cytological analysis. It is typically a compact unit with an electric motor, a vertical shaft, and a special horizontal rotor attached that enables cells to be separated from a liquid suspension and deposited directly onto a microscope slide for microscopic examination.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

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: 8618cc80-3bfc-4ead-a73c-5bfa2987b101
Public Version Date: August 22, 2023
Public Version Number: 1
DI Record Publish Date: August 14, 2023