Catalog Number

I-H2135BT01

Brand Name

Instrument

Version/Model Number

I-H2135BT01

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

-

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

K182468

Product Code

KWY

Product Code Name

Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented

Public Device Record Key

83da48e9-1f55-4c06-bacb-9dc3bb990b02

Public Version Date

May 01, 2019

Public Version Number

1

DI Record Publish Date

April 23, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-