Catalog Number

104-6301

Brand Name

STANDBY ALGINATE ALTERNATIVE 50ml CART 4/pk

Version/Model Number

104-6301

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

-

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

ELW

Product Code Name

MATERIAL, IMPRESSION

Public Device Record Key

ed0e6bff-7bf0-4253-b705-01296beefc75

Public Version Date

September 02, 2020

Public Version Number

1

DI Record Publish Date

August 25, 2020

Package DI Number

D778104630116

Quantity per Package

4

Contains DI Package

D778104630105

Package Discontinue Date

October 25, 2018

Package Status

Not in Commercial Distribution

Package Type

KIT