Catalog Number

700-115

Brand Name

Sage

Version/Model Number

700-115

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 14, 2019

Issuing Agency

In GS1

MRI safety Status

MR Safe

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FMP

Product Code Name

Protector, skin pressure

Public Device Record Key

01772b08-a6f9-4b69-bbb9-aa8d9d9f470e

Public Version Date

July 26, 2022

Public Version Number

7

DI Record Publish Date

July 01, 2019

Package DI Number

50618029980040

Quantity per Package

5

Contains DI Package

00618029980045

Package Discontinue Date

August 14, 2019

Package Status

Not in Commercial Distribution

Package Type

case