Cytuity™ - Cell Collection Catheter - BOSTON SCIENTIFIC CORPORATION

Duns Number:021717889

Device Description: Cell Collection Catheter

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More Product Details

Catalog Number

M0065907110

Brand Name

Cytuity™

Version/Model Number

M0065907110

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 30, 2020

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

HIH

Product Code Name

HYSTEROSCOPE (AND ACCESSORIES)

Device Record Status

Public Device Record Key

f7dec977-8d6c-43e7-a6ff-9b6c3b06e2a0

Public Version Date

May 29, 2020

Public Version Number

2

DI Record Publish Date

August 20, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

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