RX Locking Device and Biopsy Cap - Locking Device and Biopsy Cap For Use with RX - BOSTON SCIENTIFIC CORPORATION

Duns Number:021717889

Device Description: Locking Device and Biopsy Cap For Use with RX Biliary System

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More Product Details

Catalog Number

-

Brand Name

RX Locking Device and Biopsy Cap

Version/Model Number

M00545280

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

ODC

Product Code Name

Endoscope channel accessory

Device Record Status

Public Device Record Key

290f8fa3-adf9-4bad-9a61-2f968533b600

Public Version Date

October 23, 2019

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

08714729296638

Quantity per Package

10

Contains DI Package

08714729746690

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