Catalog Number

147500

Brand Name

ICONN Answer 4.75MM Suture Anchor

Version/Model Number

147500

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

-

Product Code

MBI

Product Code Name

Fastener, Fixation, Nondegradable, Soft Tissue

Public Device Record Key

663aa763-d10f-4b75-ae1a-4b42e68118f1

Public Version Date

March 21, 2019

Public Version Number

4

DI Record Publish Date

September 23, 2015

Package DI Number

10860419000209

Quantity per Package

12

Contains DI Package

00860419000202

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box