Catalog Number

SP38-010

Brand Name

LifeGlobal® GPS® Dishware

Version/Model Number

SP38-010

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K080395,K080395

Product Code

MQK

Product Code Name

LABWARE, ASSISTED REPRODUCTION

Public Device Record Key

62ed2dbb-fafb-485f-ba1e-9353f01d9c0e

Public Version Date

March 10, 2021

Public Version Number

4

DI Record Publish Date

March 10, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-