Catalog Number

5000

Brand Name

GUIDOR

Version/Model Number

MC

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 17, 2021

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

NPK

Product Code Name

Barrier, Synthetic, Intraoral

Public Device Record Key

da924ec2-89ea-4fae-af4e-73d76cb0e4bc

Public Version Date

August 30, 2021

Public Version Number

4

DI Record Publish Date

October 13, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-