NEOFACE - L Regular Left Miniplate - Neoortho Produtos Ortopédicos S/A.

Duns Number:914644351

Device Description: L Regular Left Miniplate

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


More Product Details

Catalog Number

-

Brand Name

NEOFACE

Version/Model Number

922.028

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

K102641

Product Code Details

Product Code

JEY

Product Code Name

Plate, Bone

Device Record Status

Public Device Record Key

8e0e12ee-38d9-49d4-b5cf-133e95b02c71

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

September 23, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NEOORTHO PRODUTOS ORTOPÉDICOS S/A." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2372