Catalog Number

-

Brand Name

Bio Protech

Version/Model Number

P9551F

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

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

K073360,K073360,K073360

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

2135ef98-20c7-4dc9-808d-7b866e627a3d

Public Version Date

June 05, 2020

Public Version Number

4

DI Record Publish Date

July 01, 2016

Package DI Number

10817120020477

Quantity per Package

50

Contains DI Package

00817120020470

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Box