Catalog Number

467-431

Brand Name

SHAPLEIGH EAR CURETTE

Version/Model Number

467-431

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

JYG

Product Code Name

CURETTE, EAR

Public Device Record Key

afa8193c-795e-4de6-93a7-87bd078b4933

Public Version Date

September 10, 2019

Public Version Number

2

DI Record Publish Date

September 13, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-