Catalog Number

60103

Brand Name

Halyard

Version/Model Number

92486

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

K932790,K932790

Product Code

KGE

Product Code Name

FORCEPS, BIOPSY, ELECTRIC

Public Device Record Key

2a42fbf6-6e74-496a-86d2-d1ab14602410

Public Version Date

November 16, 2018

Public Version Number

4

DI Record Publish Date

July 06, 2016

Package DI Number

30680651924866

Quantity per Package

5

Contains DI Package

10680651924862

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS