Video Camera Insert/Filter - Video Camera Insert/Filter - For Rigid Endoscopes - BOSTON SCIENTIFIC CORPORATION

Duns Number:021717889

Device Description: Video Camera Insert/Filter - For Rigid Endoscopes

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More Product Details

Catalog Number

-

Brand Name

Video Camera Insert/Filter

Version/Model Number

0010-0725

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

-

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

FEM

Product Code Name

Accessories, Photographic, For Endoscope (Exclude Light Sources)

Device Record Status

Public Device Record Key

6a509ac4-22b8-4f8b-9621-a58e466ccd4d

Public Version Date

April 26, 2019

Public Version Number

9

DI Record Publish Date

September 24, 2016

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