DabirAir Micropressure - Surgical Overlay (26x24") - CE - DABIR SURFACES, INC.

Duns Number:079374086

Device Description: Surgical Overlay (26x24") - CE

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More Product Details

Catalog Number

-

Brand Name

DabirAir Micropressure

Version/Model Number

DA-102624-01

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 13, 2016

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

1b9199ed-17fa-4b44-98fe-a7d67b9e2612

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 12, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DABIR SURFACES, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 104