Impact™ - IMPACT 20MMX2CMX75CM - B BRAUN INTERVENTIONAL SYSTEMS, INC

Duns Number:784259751

Device Description: IMPACT 20MMX2CMX75CM

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More Product Details

Catalog Number

202750

Brand Name

Impact™

Version/Model Number

202750

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)

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

KNQ

Product Code Name

Dilator, esophageal

Device Record Status

Public Device Record Key

300ab9a9-cb66-4b2e-a6c9-e6765145b677

Public Version Date

October 18, 2021

Public Version Number

5

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