Catalog Number

910110

Brand Name

Surgiphor

Version/Model Number

910110

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

K221504,K221504

Product Code

FQH

Product Code Name

LAVAGE, JET

Public Device Record Key

a87a04a7-faa7-4c91-b4a5-91499cdf28f9

Public Version Date

October 26, 2022

Public Version Number

1

DI Record Publish Date

October 18, 2022

Package DI Number

50382909101107

Quantity per Package

8

Contains DI Package

00382909101102

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case