PINNACLE - Pinnacle Washington State Keyed Folding Rail LH - HARMAR SUMMIT, LLC

Duns Number:144008062

Device Description: Pinnacle Washington State Keyed Folding Rail LH

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More Product Details

Catalog Number

SL600DC

Brand Name

PINNACLE

Version/Model Number

SL600

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

ILK

Product Code Name

Transport, patient, powered

Device Record Status

Public Device Record Key

81d0554a-7763-4aa1-a41a-91a29a06a417

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HARMAR SUMMIT, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 544