Catalog Number

-

Brand Name

Rotium Bioresorbable Wick

Version/Model Number

FG-0007

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

K183236,K201414,K183236,K201414,K183236,K201414

Product Code

MAI

Product Code Name

Fastener, Fixation, Biodegradable, Soft Tissue

Public Device Record Key

94a003a2-e96e-496a-b040-f1ec8c5948d5

Public Version Date

October 19, 2022

Public Version Number

2

DI Record Publish Date

April 03, 2019

Package DI Number

20852513007052

Quantity per Package

5

Contains DI Package

10852513007055

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case