Summit International - 120" COILED EXT SET, ID1.5xOD2.5MM - DRAGON HEART MEDICAL, INC.

Duns Number:841522985

Device Description: 120" COILED EXT SET, ID1.5xOD2.5MM

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More Product Details

Catalog Number

MSCE-120.1.5

Brand Name

Summit International

Version/Model Number

MSCE-120.1.5

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

April 30, 2024

Issuing Agency

In HIBCC

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

-

Product Code Details

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Device Record Status

Public Device Record Key

7b120075-c2c7-4d9c-a236-8f262bcba397

Public Version Date

May 11, 2021

Public Version Number

1

DI Record Publish Date

May 03, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DRAGON HEART MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 14