Catalog Number

SPG-101-18-07

Brand Name

SPpro GWI

Version/Model Number

SPG-101-18-07

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Unsafe

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DWS

Product Code Name

Instruments, Surgical, Cardiovascular

Public Device Record Key

8cf092a7-f7fb-42cd-99d6-f5ecf56f968a

Public Version Date

March 21, 2022

Public Version Number

1

DI Record Publish Date

March 11, 2022

Package DI Number

B339SPG10118075

Quantity per Package

25

Contains DI Package

B339SPG10118070

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case