Catalog Number

SIGTRAY

Brand Name

Signia

Version/Model Number

SIGTRAY

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K161347

Product Code

KCT

Product Code Name

Sterilization wrap containers, trays, cassettes & other accessories

Public Device Record Key

c0e0b099-5f17-4aca-a059-ace12cf584ab

Public Version Date

September 16, 2022

Public Version Number

10

DI Record Publish Date

July 31, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-