Impact™ - IMPACT BALLOON CATHETER 12MMX2CMX120CM - B BRAUN INTERVENTIONAL SYSTEMS, INC

Duns Number:784259751

Device Description: IMPACT BALLOON CATHETER 12MMX2CMX120CM

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More Product Details

Catalog Number

122120

Brand Name

Impact™

Version/Model Number

122120

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 04, 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

K931009

Product Code Details

Product Code

KNQ

Product Code Name

Dilator, esophageal

Device Record Status

Public Device Record Key

2901c70c-0a9e-4d99-a017-76cd73eca05a

Public Version Date

August 06, 2021

Public Version Number

6

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