Catalog Number

110038

Brand Name

NA

Version/Model Number

110038

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K831999,K831999

Product Code

JOL

Product Code Name

CATHETER AND TIP, SUCTION

Public Device Record Key

96d1e174-37ba-4de2-aeb3-0cd59cdc1713

Public Version Date

February 17, 2022

Public Version Number

4

DI Record Publish Date

August 29, 2015

Package DI Number

23596010033332

Quantity per Package

6

Contains DI Package

03596010033338

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX