Catalog Number

LAA1400-GYN

Brand Name

Universal Applicator incl. plug, D=3mm, L=1400mm (non sterile)

Version/Model Number

LAA1400-GYN

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

-

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

Product Code

JAQ

Product Code Name

System, Applicator, Radionuclide, Remote-Controlled

Public Device Record Key

b93f9093-c090-4f69-afed-b31d4f04877a

Public Version Date

February 07, 2019

Public Version Number

5

DI Record Publish Date

October 04, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-