Catalog Number

155-114

Brand Name

FACE CRIB TAN LARGE

Version/Model Number

155-114

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

DZB

Product Code Name

Headgear, Extraoral, Orthodontic

Public Device Record Key

52f39b27-26e5-4dcc-9fd6-340fa3e5efdc

Public Version Date

February 02, 2021

Public Version Number

3

DI Record Publish Date

May 19, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-