Catalog Number

ITSFTC01

Brand Name

Buffalo Filter

Version/Model Number

ITSFTC01

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 21, 2022

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

-

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

-

FDA Premarket Submission

-

Product Code

NKC

Product Code Name

Tubing/Tubing With Filter, Insufflation, Laparoscopic

Public Device Record Key

2c9fa0e0-a6e8-4e17-843e-91892d59905d

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

July 12, 2018

Package DI Number

20815198012193

Quantity per Package

10

Contains DI Package

00815198012199

Package Discontinue Date

April 21, 2022

Package Status

Not in Commercial Distribution

Package Type

Case