Catalog Number

13505

Brand Name

Panasil

Version/Model Number

13505

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

K082560

Product Code

ELW

Product Code Name

Material, Impression

Public Device Record Key

dd68c4a2-a408-4d82-8033-f3327ea242fe

Public Version Date

December 28, 2020

Public Version Number

1

DI Record Publish Date

December 18, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-