Catalog Number

LLA300-F

Brand Name

Flexible Catheter Single Leader, D=1.65mm, L=300mm

Version/Model Number

LLA300-F#02-5PC

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K142986,K142986

Product Code

JAQ

Product Code Name

System, Applicator, Radionuclide, Remote-Controlled

Public Device Record Key

ca6f1fb7-23c7-4229-8a20-6fa556b05a9c

Public Version Date

February 07, 2019

Public Version Number

5

DI Record Publish Date

October 06, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-