EndoTBrush Cytology Brush - Endoscopic cytology brush - ENDO-THERAPEUTICS, INC.

Duns Number:825239189

Device Description: Endoscopic cytology brush

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More Product Details

Catalog Number

ET1420

Brand Name

EndoTBrush Cytology Brush

Version/Model Number

ET1420

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FDX

Product Code Name

Endoscopic Cytology Brush

Device Record Status

Public Device Record Key

79cb41bc-f10a-4820-a5dd-546fc7a82cf3

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

10816207020133

Quantity per Package

10

Contains DI Package

00816207020136

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"ENDO-THERAPEUTICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 37
2 A medical device with a moderate to high risk that requires special controls. 85