Catalog Number

I4615M-SH

Brand Name

Nexplant

Version/Model Number

I4615M-SH

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K172630

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Public Device Record Key

bf5e36c4-4856-4de2-ad36-204ee5c3e416

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

June 01, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-