Catalog Number

610HSM-40

Brand Name

HedySeal Max Self-Sealing Sterilization Pouch

Version/Model Number

610HSM-40

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KCT

Product Code Name

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Public Device Record Key

06f401cb-c901-4dc4-a3d4-b55c7f504419

Public Version Date

July 16, 2020

Public Version Number

3

DI Record Publish Date

January 17, 2019

Package DI Number

D903610HSM401

Quantity per Package

200

Contains DI Package

D903610HSM40

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box