Zavation - 11G 20mm Balloon Flex - ZAVATION LLC

Duns Number:069472800

Device Description: 11G 20mm Balloon Flex

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More Product Details

Catalog Number

-

Brand Name

Zavation

Version/Model Number

VCF-1120-FLEX

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

GAA

Product Code Name

Needle, Aspiration And Injection, Disposable

Device Record Status

Public Device Record Key

6ff37a78-c925-4936-b6da-aa6c53c1e076

Public Version Date

July 23, 2020

Public Version Number

1

DI Record Publish Date

July 15, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ZAVATION LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 375
2 A medical device with a moderate to high risk that requires special controls. 7471
U Unclassified 22