Catalog Number

HTR-01-704138

Brand Name

NAOS

Version/Model Number

HTR-01-704138

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K041595

Product Code

KWD

Product Code Name

Prosthesis, Toe, Hemi-, Phalangeal

Public Device Record Key

ba03e909-ffb3-418b-9001-7646ea93d156

Public Version Date

April 05, 2019

Public Version Number

1

DI Record Publish Date

March 28, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-