Catalog Number

46670

Brand Name

Halyard

Version/Model Number

46670

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

K102652,K102652,K102652

Product Code

FYA

Product Code Name

GOWN, SURGICAL

Public Device Record Key

79d0a7d0-2034-4a0d-a2b4-e70d83bf8415

Public Version Date

December 27, 2021

Public Version Number

3

DI Record Publish Date

December 17, 2020

Package DI Number

30680651466700

Quantity per Package

27

Contains DI Package

20680651466703

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS