Catalog Number

10118

Brand Name

Sterrad

Version/Model Number

10118

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

K030429,K030429

Product Code

FLF

Product Code Name

Sterilizer, ethylene-oxide gas

Public Device Record Key

332929c0-fe2e-4d37-9a94-c7199fd968e2

Public Version Date

June 15, 2020

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

20705037014658

Quantity per Package

5

Contains DI Package

10705037014651

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case