Catalog Number

910100

Brand Name

Surgiphor

Version/Model Number

910100

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

K202071,K202071

Product Code

FQH

Product Code Name

LAVAGE, JET

Public Device Record Key

72bae79e-740d-4aab-a666-90bf20777787

Public Version Date

May 20, 2021

Public Version Number

1

DI Record Publish Date

May 12, 2021

Package DI Number

50382909101008

Quantity per Package

8

Contains DI Package

00382909101003

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case