Catalog Number

14712

Brand Name

Silginat

Version/Model Number

14712

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 29, 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

K082157

Product Code

ELW

Product Code Name

Material, Impression

Public Device Record Key

6f14fde6-94f9-40c1-a15d-3305b5ca4d3f

Public Version Date

July 30, 2020

Public Version Number

4

DI Record Publish Date

September 12, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-