iTClamp® - The iTClamp® quickly controls critical bleeding - INNOVATIVE TRAUMA CARE INC

Duns Number:057092294

Device Description: The iTClamp® quickly controls critical bleeding by closing the skin to create a temporary,

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More Product Details

Catalog Number

-

Brand Name

iTClamp®

Version/Model Number

9200

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K150813,K150813,K150813

Product Code Details

Product Code

DXC

Product Code Name

Clamp, Vascular

Device Record Status

Public Device Record Key

165a8f97-ec2b-40dd-ace9-ddbb1bfca712

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 22, 2016

Additional Identifiers

Package DI Number

10854874004032

Quantity per Package

10

Contains DI Package

00854874004035

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"INNOVATIVE TRAUMA CARE INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2