Catalog Number

MDIC5454150

Brand Name

Icon Surgical

Version/Model Number

MDIC5454150

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K101689,K101689,K101689

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

e677729c-4861-495c-995d-16b92797cd2f

Public Version Date

February 06, 2020

Public Version Number

2

DI Record Publish Date

August 08, 2019

Package DI Number

00850003355573

Quantity per Package

1

Contains DI Package

00850003355566

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case