Catalog Number

CI-STPEA

Brand Name

Steam Autoclave Tape

Version/Model Number

18mm

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 30, 2016

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

K080307

Product Code

JOJ

Product Code Name

Indicator, Physical/Chemical Sterilization Process

Public Device Record Key

90fefc71-bac0-442e-aa6c-f5c19b6dc587

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 29, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-