Catalog Number

SBN

Brand Name

SP-Tip

Version/Model Number

SBN

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"

-

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

a6e9c05d-84af-46ac-abb9-f0a7c44a56b4

Public Version Date

September 27, 2021

Public Version Number

1

DI Record Publish Date

September 19, 2021

Package DI Number

00810026180958

Quantity per Package

25

Contains DI Package

00810026181009

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case