Catalog Number

70103318 L

Brand Name

Disposable E-Prop Mouth Props Large

Version/Model Number

70103318 L

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

-

Product Code

BRW

Product Code Name

Protector, Dental

Public Device Record Key

82125a1f-8206-49bd-9aca-2ee99c8481ff

Public Version Date

April 27, 2022

Public Version Number

1

DI Record Publish Date

April 19, 2022

Package DI Number

00723896021361

Quantity per Package

50

Contains DI Package

00723896021354

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE