Signature - Signature Planner - Materialise NV

Duns Number:373139427

Device Description: Signature Planner

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More Product Details

Catalog Number

Signature Planner

Brand Name

Signature

Version/Model Number

Signature Planner

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 01, 2019

Issuing Agency

In HIBCC

Product Characteristics

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K140257

Product Code Details

Product Code

JWH

Product Code Name

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Device Record Status

Public Device Record Key

e3bf5d63-078e-4647-a69d-24ac4b509aa2

Public Version Date

February 21, 2022

Public Version Number

5

DI Record Publish Date

February 10, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MATERIALISE NV" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 91
2 A medical device with a moderate to high risk that requires special controls. 296