Catalog Number

61447

Brand Name

Halyard

Version/Model Number

92791

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

LRO

Product Code Name

General surgery tray (kit)

Public Device Record Key

4a4ed1f1-7211-4fb9-9d5b-db58f5427cb1

Public Version Date

December 13, 2021

Public Version Number

8

DI Record Publish Date

July 20, 2016

Package DI Number

30680651927911

Quantity per Package

4

Contains DI Package

10680651927917

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS