Catalog Number

NL-SK-6

Brand Name

GelMat Consumable

Version/Model Number

NL-SK-2-212

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

K170585

Product Code

LBI

Product Code Name

Unit, Neonatal Phototherapy

Public Device Record Key

b8a4882c-214f-451a-9095-ef36842f10cb

Public Version Date

August 24, 2020

Public Version Number

3

DI Record Publish Date

November 09, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-