Winco - 567 XL Cozy Comfort Premier Recliner - WINCO MFG., LLC

Duns Number:963886457

Device Description: 567 XL Cozy Comfort Premier Recliner

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More Product Details

Catalog Number

567

Brand Name

Winco

Version/Model Number

567

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

-

Product Code Details

Product Code

FRJ

Product Code Name

Chair, Geriatric

Device Record Status

Public Device Record Key

12986c02-11a1-42bb-becc-a3c132fd43f0

Public Version Date

January 07, 2019

Public Version Number

1

DI Record Publish Date

December 07, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WINCO MFG., LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 83
2 A medical device with a moderate to high risk that requires special controls. 4