Knee Instruments - Femoral S5+ Sphere Instrument Set / No carton box - Medacta International SA

Duns Number:488227125

Device Description: Femoral S5+ Sphere Instrument Set / No carton box

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More Product Details

Catalog Number

-

Brand Name

Knee Instruments

Version/Model Number

11.11115

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

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

-

Product Code Details

Product Code

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Device Record Status

Public Device Record Key

bf80c6fa-80f4-47d6-9fbd-3799a02254c5

Public Version Date

April 08, 2021

Public Version Number

1

DI Record Publish Date

March 31, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDACTA INTERNATIONAL SA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8200
2 A medical device with a moderate to high risk that requires special controls. 9084