Multi-Snare® - MULTI-SNARE SET 5MMX125CM W/4FRX105CM - B BRAUN INTERVENTIONAL SYSTEMS, INC

Duns Number:784259751

Device Description: MULTI-SNARE SET 5MMX125CM W/4FRX105CM

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More Product Details

Catalog Number

612972

Brand Name

Multi-Snare®

Version/Model Number

612972

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 09, 2021

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K011783

Product Code Details

Product Code

DXE

Product Code Name

CATHETER, EMBOLECTOMY

Device Record Status

Public Device Record Key

304df85e-72ed-4d52-9a74-1b0123dfb333

Public Version Date

July 12, 2021

Public Version Number

7

DI Record Publish Date

August 09, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"B BRAUN INTERVENTIONAL SYSTEMS, INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1226
3 A medical device with high risk that requires premarket approval 361