Catalog Number

SP-9100

Brand Name

Defend

Version/Model Number

SP-9100

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"

-

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

K143637

Product Code

FRG

Product Code Name

Wrap, Sterilization

Public Device Record Key

591ae59c-3e82-4785-9f09-e561b5871bd7

Public Version Date

September 27, 2022

Public Version Number

6

DI Record Publish Date

September 01, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-