Catalog Number

250-070-500

Brand Name

StrykeFlow

Version/Model Number

0250070500

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

K934094,K934094

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

faf6eb77-46a8-4527-99c6-ba13312a0350

Public Version Date

October 14, 2021

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

37613327061391

Quantity per Package

6

Contains DI Package

07613327061390

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack