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

Device Identifier (DI) Information

Microscope slides, 1/2G, uncoated, for Cytopro
SS-117
In Commercial Distribution
SS-117
ELITECHGROUP INC.
03661540302718
GS1

1
052423787 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
Yes
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

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
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FDA Product Code

[?]
Product Code Product Code Name
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

8618cc80-3bfc-4ead-a73c-5bfa2987b101
August 22, 2023
1
August 14, 2023
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1 (800) 453-2725
info@elitechgroup.com
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