SportMeds Instruments - Hip arthro - Access Kit Light - Medacta International SA

Duns Number:488227125

Device Description: Hip arthro - Access Kit Light

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More Product Details

Catalog Number

-

Brand Name

SportMeds Instruments

Version/Model Number

05.11.10.0044

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

GAA

Product Code Name

Needle, Aspiration And Injection, Disposable

Device Record Status

Public Device Record Key

7f42b7e3-9a98-412c-801f-29ef8f6faf48

Public Version Date

April 14, 2022

Public Version Number

1

DI Record Publish Date

April 06, 2022

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