Catalog Number

-

Brand Name

Ally UPS Adapter Drape for Advincula Delineator

Version/Model Number

AU-AD-DLNTR

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K141523,K141523

Product Code

LKF

Product Code Name

Cannula, Manipulator/Injector, Uterine

Public Device Record Key

40cb727b-dc07-4c28-bfe7-1ed77808f106

Public Version Date

February 06, 2020

Public Version Number

2

DI Record Publish Date

December 03, 2018

Package DI Number

20888937019951

Quantity per Package

20

Contains DI Package

00888937019957

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box