Catalog Number

90121

Brand Name

C-Core

Version/Model Number

90121

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K101598,K101598

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

05918723-c8b4-4d73-b0aa-721fc6e41bb1

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

March 06, 2020

Package DI Number

00817602022602

Quantity per Package

44

Contains DI Package

00817602022596

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case