Catalog Number

2770-100-000

Brand Name

SofCare

Version/Model Number

2770

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KIC

Product Code Name

CUSHION, FLOTATION

Public Device Record Key

0c6f1d7a-e47d-4e54-b1d4-826a5b3a7cc9

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Package DI Number

57613327175337

Quantity per Package

6

Contains DI Package

07613327175332

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case