FAICO CMF System - Fracture screw. EMERGENCY. CROSS HEAD. D.2.7x20mm - FAICO MEDICAL LLC

Duns Number:081290972

Device Description: Fracture screw. EMERGENCY. CROSS HEAD. D.2.7x20mm - Self-Tapping

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

FAICO CMF System

Version/Model Number

FRMS-2.7-EC-20.0-TI-SC

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

-

Product Code Details

Product Code

DZL

Product Code Name

Screw, Fixation, Intraosseous

Device Record Status

Public Device Record Key

1b3b8eff-c7fc-47a3-8089-0ed2c1d2e2ea

Public Version Date

April 19, 2021

Public Version Number

2

DI Record Publish Date

September 26, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FAICO MEDICAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 425
2 A medical device with a moderate to high risk that requires special controls. 1392