IMPIX-ALIF S/A - IMPIX ALIF S/A TRIAL LARGE 14mm - 15° - MEDICREA INTERNATIONAL

Duns Number:383228632

Device Description: IMPIX ALIF S/A TRIAL LARGE 14mm - 15°

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


More Product Details

Catalog Number

-

Brand Name

IMPIX-ALIF S/A

Version/Model Number

A15221415

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

-

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

HWT

Product Code Name

Template

Device Record Status

Public Device Record Key

b379dc5d-c855-4ab6-9dc2-7347370c1568

Public Version Date

May 23, 2022

Public Version Number

6

DI Record Publish Date

February 01, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDICREA INTERNATIONAL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1328
2 A medical device with a moderate to high risk that requires special controls. 3995