Catalog Number

-

Brand Name

Tilcare

Version/Model Number

CATHETER TIP WITH COVER 60ML

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KYX

Product Code Name

Dispenser, Liquid Medication

Public Device Record Key

21b0d205-0efa-40e7-8256-328edc5914c7

Public Version Date

October 29, 2021

Public Version Number

2

DI Record Publish Date

September 18, 2019

Package DI Number

35060665920170

Quantity per Package

10

Contains DI Package

05060665920179

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-