Catalog Number

ASUP111318

Brand Name

Adelante SafeSheath Ultra Lite

Version/Model Number

ASUP111318

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

K122084,K122084

Product Code

DYB

Product Code Name

INTRODUCER, CATHETER

Public Device Record Key

12b88deb-f483-4229-a283-21fdd44c37c8

Public Version Date

June 07, 2019

Public Version Number

4

DI Record Publish Date

November 16, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-