Catalog Number

-

Brand Name

Bio Protech

Version/Model Number

P9552F

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

3b480936-b79c-450e-a977-f58b810e4d95

Public Version Date

June 05, 2020

Public Version Number

4

DI Record Publish Date

July 01, 2016

Package DI Number

20817120020481

Quantity per Package

2

Contains DI Package

10817120020484

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case