Setmark Incorporated - Aluminum Stretcher, cut style frame with casters, - SETMARK INC.

Duns Number:080798558

Device Description: Aluminum Stretcher, cut style frame with casters, less pad w/ Medical grade plastic top 50 Aluminum Stretcher, cut style frame with casters, less pad w/ Medical grade plastic top 500lb capacity

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More Product Details

Catalog Number

-

Brand Name

Setmark Incorporated

Version/Model Number

NF-106

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

FPO

Product Code Name

Stretcher, Wheeled

Device Record Status

Public Device Record Key

b0de5e51-502b-46af-a517-458093ea8075

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 31, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SETMARK INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 22
2 A medical device with a moderate to high risk that requires special controls. 5