Catalog Number

-

Brand Name

M-ARS ACL: Anatomic Ribbon Surgery System

Version/Model Number

05.05.0002

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K171640

Product Code

MBI

Product Code Name

Fastener, Fixation, Nondegradable, Soft Tissue

Public Device Record Key

1778654a-792b-48cd-b6f0-9a2da0e091a2

Public Version Date

January 08, 2019

Public Version Number

4

DI Record Publish Date

October 28, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-