Catalog Number

AP1603142

Brand Name

Aquatec Ocean Ergo Standard Soft Seat

Version/Model Number

AP1603142

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

INN

Product Code Name

CHAIR, ADJUSTABLE, MECHANICAL

Public Device Record Key

d3378346-4ef8-405c-ba79-75d1d07e2d6c

Public Version Date

October 29, 2019

Public Version Number

1

DI Record Publish Date

October 21, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-