IsoTour - STRYKER CORPORATION

Duns Number:078470558

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More Product Details

Catalog Number

2872-001-004

Brand Name

IsoTour

Version/Model Number

2872

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

FNM

Product Code Name

MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Device Record Status

Public Device Record Key

fab0fb52-bacd-4265-9fbd-4bafa3319430

Public Version Date

December 25, 2019

Public Version Number

1

DI Record Publish Date

December 17, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STRYKER CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2188
2 A medical device with a moderate to high risk that requires special controls. 3183
U Unclassified 60