COMPASS ™ - COMPASS 4F X 45CM HEMO STRAIGHT - B BRAUN INTERVENTIONAL SYSTEMS, INC

Duns Number:784259751

Device Description: COMPASS 4F X 45CM HEMO STRAIGHT

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More Product Details

Catalog Number

613945

Brand Name

COMPASS ™

Version/Model Number

613945

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"

-

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

K181463,K181463

Product Code Details

Product Code

DRE

Product Code Name

DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Device Record Status

Public Device Record Key

fa81b07f-8286-4fef-b094-ea44b4d44ba3

Public Version Date

December 15, 2021

Public Version Number

1

DI Record Publish Date

December 07, 2021

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