SafetyFix Easy Out - 2.5MM CORTICAL SCREW, CANNULATED, 1.9 MM HEAD, - Safetyfix Medical Technologies

Duns Number:094825235

Device Description: 2.5MM CORTICAL SCREW, CANNULATED, 1.9 MM HEAD, LENGTH 30

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More Product Details

Catalog Number

22761-0001-1.9-30

Brand Name

SafetyFix Easy Out

Version/Model Number

2.5MM CORTICAL SCREW, CANNULATED, 1.9 MM HEAD, LENGTH 30

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

K180753

Product Code Details

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Device Record Status

Public Device Record Key

d1097713-f743-4d20-9f30-7d1f3814ab4f

Public Version Date

September 24, 2019

Public Version Number

3

DI Record Publish Date

May 08, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SAFETYFIX MEDICAL TECHNOLOGIES" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 58