Catalog Number

-

Brand Name

Biotem

Version/Model Number

FXIR5515

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K171185

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Public Device Record Key

8bc5b6c5-8cee-4ea7-9a40-5419342dbdc0

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

-