Catalog Number

37250

Brand Name

Halyard

Version/Model Number

37250

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)

Yes

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

ISR

Product Code Name

BAND OR BELT, PELVIC SUPPORT

Public Device Record Key

39f79d22-8f0f-4628-908e-021742379eff

Public Version Date

April 21, 2021

Public Version Number

2

DI Record Publish Date

November 16, 2020

Package DI Number

30680651372506

Quantity per Package

2

Contains DI Package

20680651372509

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS