Catalog Number

FL-2107

Brand Name

Key Surgical

Version/Model Number

FL-2107

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)

-

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

b3cf1856-7ef4-481d-a88d-a80ebe60eab3

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

December 03, 2020

Package DI Number

50628725005626

Quantity per Package

20

Contains DI Package

00628725005621

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case