NA - Ext. Hex Cylindrical Implant, Ultra-Short, Ø3.75 - SOUTHERN IMPLANTS (PTY) LTD

Duns Number:636239584

Device Description: Ext. Hex Cylindrical Implant, Ultra-Short, Ø3.75 x 4mm

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


More Product Details

Catalog Number

-

Brand Name

NA

Version/Model Number

IE4

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

K161548

Product Code Details

Product Code

FZE

Product Code Name

Prosthesis, Nose, Internal

Device Record Status

Public Device Record Key

1d652abf-4d4c-4367-a447-4bc0cbe265b9

Public Version Date

September 14, 2022

Public Version Number

2

DI Record Publish Date

January 15, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SOUTHERN IMPLANTS (PTY) LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1050
2 A medical device with a moderate to high risk that requires special controls. 1479