Catalog Number

CG-SM-M

Brand Name

Clear Guide SteriMASK

Version/Model Number

CGSMM

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Safe

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

PUI

Product Code Name

Drape, Surgical, Exempt

Public Device Record Key

33153273-0df7-402e-b320-5cfb1b2f138a

Public Version Date

October 11, 2022

Public Version Number

1

DI Record Publish Date

October 03, 2022

Package DI Number

B201CGSMM1

Quantity per Package

20

Contains DI Package

B201CGSMM0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box