Armadillo - SelectFlex II 072 Neurovascular Access System - Q'APEL MEDICAL LLC

Duns Number:020937374

Device Description: SelectFlex II 072 Neurovascular Access System 95cm, 22cm Variable Stiffness, 30cm Coating

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More Product Details

Catalog Number

SF7072-95-22-30

Brand Name

Armadillo

Version/Model Number

FG 00464-04

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

-

Product Code Details

Product Code

DQY

Product Code Name

Catheter, Percutaneous

Device Record Status

Public Device Record Key

d96eb7e8-ee1e-437a-81a5-add8489483f0

Public Version Date

January 24, 2022

Public Version Number

1

DI Record Publish Date

January 16, 2022

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