Catalog Number

-

Brand Name

Soma Safe Enclosure

Version/Model Number

SSE 425

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

FNL

Product Code Name

BED, AC-POWERED ADJUSTABLE HOSPITAL

Public Device Record Key

86db3527-fbd8-4172-ab7b-b1ef31c38144

Public Version Date

September 07, 2020

Public Version Number

1

DI Record Publish Date

August 30, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-