Catalog Number

590-10011

Brand Name

Health-Tec Sterilization Wrap

Version/Model Number

590-10011

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FRG

Product Code Name

Wrap, Sterilization

Public Device Record Key

263dabf7-9319-46e4-b381-180c4192596b

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

January 24, 2017

Package DI Number

D773590100115

Quantity per Package

5

Contains DI Package

D773590100111

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-