VYGON - Control suction catheter - Ø2.3mm - 07Fr - L.290mm - VYGON

Duns Number:392994778

Device Description: Control suction catheter - Ø2.3mm - 07Fr - L.290mm

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More Product Details

Catalog Number

00053507

Brand Name

VYGON

Version/Model Number

535.07

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

BSY

Product Code Name

CATHETERS, SUCTION, TRACHEOBRONCHIAL

Device Record Status

Public Device Record Key

9e794167-d15b-4a25-a769-9e1610ca3130

Public Version Date

June 17, 2021

Public Version Number

1

DI Record Publish Date

June 09, 2021

Additional Identifiers

Package DI Number

33660812115521

Quantity per Package

50

Contains DI Package

03660812115520

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"VYGON" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 15
2 A medical device with a moderate to high risk that requires special controls. 195