Cook - Cytology Brush Gastroscope - COOK INCORPORATED

Duns Number:079720472

Device Description: Cytology Brush Gastroscope

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More Product Details

Catalog Number

ECB-5-180-2-S

Brand Name

Cook

Version/Model Number

G22409

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"

-

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

65a14ceb-018f-4659-aed5-9e13cd648d24

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

10827002224091

Quantity per Package

10

Contains DI Package

00827002224094

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"COOK INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 669
2 A medical device with a moderate to high risk that requires special controls. 8328
3 A medical device with high risk that requires premarket approval 370
U Unclassified 242