Orca® - Single Use Air/Water and Suction Valves - BOSTON SCIENTIFIC CORPORATION

Duns Number:021717889

Device Description: Single Use Air/Water and Suction Valves

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More Product Details

Catalog Number

SUV-618-01

Brand Name

Orca®

Version/Model Number

SUV-618-01

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

61e9cc82-8814-4899-b600-d8bf63d5e036

Public Version Date

May 24, 2019

Public Version Number

1

DI Record Publish Date

May 16, 2019

Additional Identifiers

Package DI Number

08714729993698

Quantity per Package

50

Contains DI Package

08714729993728

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