OS2®-V - Varisation staple Inox - IN2BONES

Duns Number:263616749

Device Description: Varisation staple Inox

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More Product Details

Catalog Number

-

Brand Name

OS2®-V

Version/Model Number

T10 SS900

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K143323

Product Code Details

Product Code

JDR

Product Code Name

Staple, Fixation, Bone

Device Record Status

Public Device Record Key

7b48d629-6670-4b07-ad43-4fea237112f5

Public Version Date

November 23, 2021

Public Version Number

4

DI Record Publish Date

August 28, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IN2BONES" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 281
2 A medical device with a moderate to high risk that requires special controls. 608