POSEY - STRYKER S3 SEIZURE SIDE RAIL PADS LEFT UPPER - POSEY PRODUCTS, LLC

Duns Number:008503294

Device Description: STRYKER S3 SEIZURE SIDE RAIL PADS LEFT UPPER

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More Product Details

Catalog Number

5766LU

Brand Name

POSEY

Version/Model Number

5766LU

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 09, 2021

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

FNL

Product Code Name

Bed, Ac-Powered Adjustable Hospital

Device Record Status

Public Device Record Key

7d8fec10-ebb7-4b7b-9ca4-84a610ae8b99

Public Version Date

January 21, 2022

Public Version Number

3

DI Record Publish Date

September 13, 2016

Additional Identifiers

Package DI Number

20190676000849

Quantity per Package

4

Contains DI Package

10190676000842

Package Discontinue Date

July 09, 2021

Package Status

Not in Commercial Distribution

Package Type

CS

"POSEY PRODUCTS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 177
2 A medical device with a moderate to high risk that requires special controls. 77