Catalog Number

625-973

Brand Name

OrthoStore - REPLICA, MINT FLAVOR ALGINATE

Version/Model Number

625-973

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

K925746

Product Code

ELW

Product Code Name

Material, Impression

Public Device Record Key

48224026-ef35-471a-a411-495001597489

Public Version Date

September 27, 2022

Public Version Number

4

DI Record Publish Date

February 23, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-