Inion FreedomPin Instruments - Trocar tip drill 2.0 mm - Inion Oy

Duns Number:367994657

Device Description: Trocar tip drill 2.0 mm

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More Product Details

Catalog Number

INS-9238

Brand Name

Inion FreedomPin Instruments

Version/Model Number

1

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

-

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 Details

Product Code

NBH

Product Code Name

Accessories, arthroscopic

Device Record Status

Public Device Record Key

11146009-0367-4dff-860a-8e120361b172

Public Version Date

May 18, 2020

Public Version Number

1

DI Record Publish Date

May 08, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INION OY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 201
2 A medical device with a moderate to high risk that requires special controls. 473