Catalog Number

-

Brand Name

ConMed Linvatec

Version/Model Number

SDPS-C011

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K172092

Product Code

HRX

Product Code Name

Arthroscope

Public Device Record Key

51e92399-d940-4847-9b2f-3c292a23cb51

Public Version Date

September 28, 2022

Public Version Number

2

DI Record Publish Date

August 15, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-