Catalog Number

625-100

Brand Name

OrthoStore - BUBBLEGUM

Version/Model Number

625-100

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K940120

Product Code

ELW

Product Code Name

Material, Impression

Public Device Record Key

e77a41e2-1043-4391-b8d0-a9485d70181a

Public Version Date

September 27, 2022

Public Version Number

4

DI Record Publish Date

February 19, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-