Catalog Number

-

Brand Name

Soma Safe Enclosure

Version/Model Number

SSE 300e

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FNM

Product Code Name

MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Public Device Record Key

e71e1d65-bdde-4a0b-a471-d21eb58ac65a

Public Version Date

March 19, 2020

Public Version Number

1

DI Record Publish Date

March 11, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-