STR MAT-5X30X76-2T-STD FOAM-CAL117-PU - STR MAT-5X30X76-2T-STD FOAM-CAL117-PU - CURBELL MEDICAL PRODUCTS, INC.

Duns Number:796452311

Device Description: STR MAT-5X30X76-2T-STD FOAM-CAL117-PU

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More Product Details

Catalog Number

23112

Brand Name

STR MAT-5X30X76-2T-STD FOAM-CAL117-PU

Version/Model Number

SM-53076-2T-SF117-PU

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 16, 2020

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

FPP

Product Code Name

Stretcher, Hand-Carried

Device Record Status

Public Device Record Key

0cb8e0fe-c2bc-4291-944a-2d68e5be248e

Public Version Date

September 17, 2020

Public Version Number

2

DI Record Publish Date

April 06, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CURBELL MEDICAL PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 478
2 A medical device with a moderate to high risk that requires special controls. 8062