Catalog Number

-

Brand Name

Solar GI air-charged 4P, Compact Pole system

Version/Model Number

G3-7 Air

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"

Yes

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

K121014

Product Code

FFX

Product Code Name

SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)

Public Device Record Key

6a6f9e0b-96d9-42da-9e72-346625d0a2e8

Public Version Date

May 16, 2022

Public Version Number

1

DI Record Publish Date

May 07, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-