Catalog Number

0921051

Brand Name

Bosworth Gorilla Seal

Version/Model Number

0921051

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 12, 2019

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

K051224,K051224

Product Code

EBC

Product Code Name

SEALANT, PIT AND FISSURE, AND CONDITIONER

Public Device Record Key

ff163eac-489d-4fd7-a43a-8530625c9f9b

Public Version Date

December 23, 2019

Public Version Number

4

DI Record Publish Date

September 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-