Catalog Number

29583

Brand Name

EXEL Dermal Curette

Version/Model Number

29583

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"

Yes

For Single-Use

Yes

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

FZS

Product Code Name

Curette, Surgical, General Use

Public Device Record Key

9f6ad1d2-a4f0-4934-b69e-0559405b726d

Public Version Date

July 23, 2019

Public Version Number

1

DI Record Publish Date

July 15, 2019

Package DI Number

20020221295836

Quantity per Package

6

Contains DI Package

10020221295839

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case