Catalog Number

60103

Brand Name

AVANOS

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

9fc93902-9318-4835-ab69-5bf2f88e0741

Public Version Date

May 25, 2020

Public Version Number

1

DI Record Publish Date

May 15, 2020

Package DI Number

10350770924868

Quantity per Package

5

Contains DI Package

00350770924861

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS