Catalog Number

SST-B3

Brand Name

Sp-Tip

Version/Model Number

SST-B3

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K183611,K183611

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

412eaddd-9f0d-44ef-b0f6-fdc10e1a3781

Public Version Date

April 12, 2021

Public Version Number

2

DI Record Publish Date

January 18, 2021

Package DI Number

00810026182020

Quantity per Package

25

Contains DI Package

00810026181054

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case