Catalog Number

480010

Brand Name

Gelseal™

Version/Model Number

480010

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K002007

Product Code

MAL

Product Code Name

GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE

Public Device Record Key

76c06cdf-86b2-4228-b776-d5135f128471

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

October 22, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-