Catalog Number

PHB-001U

Brand Name

PH Band

Version/Model Number

41111-01

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

K201695,K201695

Product Code

DXC

Product Code Name

Clamp, Vascular

Public Device Record Key

1623304b-b5d6-40e8-972e-e8cfce345ef0

Public Version Date

April 30, 2021

Public Version Number

1

DI Record Publish Date

April 22, 2021

Package DI Number

10860006401709

Quantity per Package

10

Contains DI Package

00860006401702

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-