Catalog Number

FS-250D

Brand Name

FloraSeal

Version/Model Number

FS250D

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"

Yes

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

K083354,K083354

Product Code

NZP

Product Code Name

Sealant, Microbial

Public Device Record Key

243993ac-0edf-4ecc-87dd-817e6842fc70

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 21, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-