INVERTA® - INVERTA®, Ø5.2 ExHex, Ø6.0 x 10mm - SOUTHERN IMPLANTS (PTY) LTD

Duns Number:636239584

Device Description: INVERTA®, Ø5.2 ExHex, Ø6.0 x 10mm

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More Product Details

Catalog Number

IV-EX52-6010

Brand Name

INVERTA®

Version/Model Number

IV-EX52-6010

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

K181850

Product Code Details

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Device Record Status

Public Device Record Key

4ea3d5f3-8e24-4978-8920-63b36f51e2e3

Public Version Date

September 06, 2022

Public Version Number

2

DI Record Publish Date

November 22, 2021

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