Drive System (Straub Medical®) - The Drive System consists of three components; - Straub Medical AG

Duns Number:488489766

Device Description: The Drive System consists of three components; the control unit, motor (with cable) and fo The Drive System consists of three components; the control unit, motor (with cable) and footswitch (with cable).

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More Product Details

Catalog Number

80300

Brand Name

Drive System (Straub Medical®)

Version/Model Number

Version 1.0

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

-

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

MCW

Product Code Name

Catheter, Peripheral, Atherectomy

Device Record Status

Public Device Record Key

1ea921b0-be3b-4eea-9529-d97691f168fe

Public Version Date

June 07, 2022

Public Version Number

4

DI Record Publish Date

January 31, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STRAUB MEDICAL AG" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 34