Catalog Number

13481

Brand Name

Panasil

Version/Model Number

13481

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 30, 2020

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

K083701

Product Code

ELW

Product Code Name

Material, Impression

Public Device Record Key

b8317c04-2ba6-4f12-ad43-6ddb59a8f9fd

Public Version Date

July 31, 2020

Public Version Number

4

DI Record Publish Date

September 07, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-