Catalog Number

1103-211

Brand Name

FEMORAL HEAD DISARTICULATOR KNIFE

Version/Model Number

1103-211

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

-

Product Code

HTS

Product Code Name

KNIFE, ORTHOPEDIC

Public Device Record Key

a172b5c2-dfe8-42be-a34a-003f48d924cf

Public Version Date

June 10, 2019

Public Version Number

3

DI Record Publish Date

October 24, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-