Catalog Number

-

Brand Name

Alleset

Version/Model Number

Model 37-2003-S

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)

-

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

44a7b9a2-f9ed-4c55-82c0-f742c9819de3

Public Version Date

February 12, 2021

Public Version Number

1

DI Record Publish Date

February 04, 2021

Package DI Number

26931918120475

Quantity per Package

25

Contains DI Package

16931918120478

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton