Catalog Number

SP-2433

Brand Name

N/A

Version/Model Number

SP-2433

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 30, 2020

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

-

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

-

FDA Premarket Submission

K972074

Product Code

GCX

Product Code Name

APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Public Device Record Key

e1ce85be-44ad-4289-8ea8-7dda322bafab

Public Version Date

July 31, 2020

Public Version Number

4

DI Record Publish Date

October 11, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-