AcuTie - AcuTie Sternum Plate - ACUTE INNOVATIONS LLC

Duns Number:619225415

Device Description: AcuTie Sternum Plate

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More Product Details

Catalog Number

-

Brand Name

AcuTie

Version/Model Number

STW1101

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 03, 2021

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

-

Product Code Details

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Device Record Status

Public Device Record Key

8a64cbc7-f9e1-498f-a5fa-a79455c935ff

Public Version Date

April 12, 2021

Public Version Number

3

DI Record Publish Date

September 16, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ACUTE INNOVATIONS LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 34