Catalog Number

610HSP-30

Brand Name

HedySeal PRO Self-Sealing Sterilization Pouches

Version/Model Number

610HSP-30

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

2c8d826c-ac5f-45d4-a979-b47635e2716b

Public Version Date

July 16, 2020

Public Version Number

3

DI Record Publish Date

January 17, 2019

Package DI Number

D903610HSP302

Quantity per Package

6

Contains DI Package

D903610HSP301

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE