Catalog Number

250-070-530

Brand Name

StrykeFlow

Version/Model Number

0250070530

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

K963646,K963646

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Public Device Record Key

c99d7c5b-8c24-4e2b-acc6-ddb99c8e6220

Public Version Date

April 23, 2019

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

37613327061353

Quantity per Package

6

Contains DI Package

07613327061352

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack