Wahoo - SelectFlex 072 Neurovascular Access System, 105cm - Q'APEL MEDICAL LLC

Duns Number:020937374

Device Description: SelectFlex 072 Neurovascular Access System, 105cm

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More Product Details

Catalog Number

SF7072-105

Brand Name

Wahoo

Version/Model Number

FG 00074

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K191664

Product Code Details

Product Code

DQY

Product Code Name

Catheter, Percutaneous

Device Record Status

Public Device Record Key

108a19ca-132c-4734-a881-fa871c2d82b7

Public Version Date

December 22, 2021

Public Version Number

3

DI Record Publish Date

June 29, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"Q'APEL MEDICAL LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 7