Catalog Number

130-00536

Brand Name

PINNACLE

Version/Model Number

SL600

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K091858

Product Code

ILK

Product Code Name

Transport, patient, powered

Public Device Record Key

ea08c257-86d6-4165-845a-204f515f96a4

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 04, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-