Catalog Number

-

Brand Name

Surestream

Version/Model Number

011719

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"

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

-

Product Code

BYH

Product Code Name

DRAIN, TEE (WATER TRAP)

Public Device Record Key

ff53442c-1709-41db-ad6d-55f8e0b425cd

Public Version Date

August 05, 2022

Public Version Number

5

DI Record Publish Date

September 28, 2018

Package DI Number

30884521552276

Quantity per Package

25

Contains DI Package

20884521552279

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE