Sofia 5F-115cm STR - Stroke Access - MICROVENTION INC.

Duns Number:003263105

Device Description: Stroke Access

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More Product Details

Catalog Number

DA5115ST

Brand Name

Sofia 5F-115cm STR

Version/Model Number

DA5115ST

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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)

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

DQO

Product Code Name

CATHETER, INTRAVASCULAR, DIAGNOSTIC

Device Record Status

Public Device Record Key

3435c202-e07f-46b5-ad45-62ded76864d0

Public Version Date

March 28, 2022

Public Version Number

8

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MICROVENTION INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1709
3 A medical device with high risk that requires premarket approval 105