NaviGuide - Percutaneous Access Needle - BOSTON SCIENTIFIC CORPORATION

Duns Number:021717889

Device Description: Percutaneous Access Needle

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More Product Details

Catalog Number

-

Brand Name

NaviGuide

Version/Model Number

M0067001340

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

GBO

Product Code Name

CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Device Record Status

Public Device Record Key

3b7e6410-f2f9-48ee-b986-b614f1e28e28

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 12, 2017

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