Compliance EndoKit™ - Compliance EndoKit - BOSTON SCIENTIFIC CORPORATION

Duns Number:021717889

Device Description: Compliance EndoKit

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More Product Details

Catalog Number

CEK-1007

Brand Name

Compliance EndoKit™

Version/Model Number

CEK-1007

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

MNL

Product Code Name

ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE

Device Record Status

Public Device Record Key

7e99739c-1f51-482a-a40c-470dce9d177b

Public Version Date

October 23, 2019

Public Version Number

3

DI Record Publish Date

November 05, 2018

Additional Identifiers

Package DI Number

00840253119025

Quantity per Package

20

Contains DI Package

00840253119568

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"BOSTON SCIENTIFIC CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 536
2 A medical device with a moderate to high risk that requires special controls. 8659
3 A medical device with high risk that requires premarket approval 1821
U Unclassified 35