Catalog Number

-

Brand Name

Acu-Dispo-Curette

Version/Model Number

R03

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

K891334,K891334,K891334,K891334

Product Code

FZS

Product Code Name

Curette, Surgical, General Use

Public Device Record Key

fba4c518-8848-4cbc-b55b-76db134bf027

Public Version Date

September 30, 2020

Public Version Number

1

DI Record Publish Date

September 22, 2020

Package DI Number

10814105020026

Quantity per Package

25

Contains DI Package

00814105020029

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box