Catalog Number

SS-SA-09

Brand Name

H. Lee SafeSheath® Sealing Adapter

Version/Model Number

00884450162118

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DTL

Product Code Name

Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass

Public Device Record Key

34978625-792e-49c0-84d2-aa41fe9f84c6

Public Version Date

March 30, 2021

Public Version Number

4

DI Record Publish Date

March 30, 2017

Package DI Number

10884450162115

Quantity per Package

5

Contains DI Package

00884450162118

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-