Summit International - 360" Coiled extension set - DRAGON HEART MEDICAL, INC.

Duns Number:841522985

Device Description: 360" Coiled extension set

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More Product Details

Catalog Number

SMES360

Brand Name

Summit International

Version/Model Number

SMES360

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

0d3b2999-4a86-4915-9ece-2942bef950d4

Public Version Date

May 12, 2021

Public Version Number

1

DI Record Publish Date

May 04, 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