Catalog Number

-

Brand Name

Bio Protech

Version/Model Number

Pro-Pencil: SRH

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K092732,K092732,K092732

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

ad88e545-5d64-4110-bca5-15469d4d3eb0

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 29, 2016

Package DI Number

10817120020262

Quantity per Package

20

Contains DI Package

00817120020265

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Box