Catalog Number

A700-DC7

Brand Name

SHARD

Version/Model Number

A700-DC7

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)

Yes

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

HNZ

Product Code Name

Curette, Ophthalmic

Public Device Record Key

ac5259c1-afef-4148-bc1e-09bfb7817ee4

Public Version Date

March 24, 2022

Public Version Number

1

DI Record Publish Date

March 16, 2022

Package DI Number

10814639025115

Quantity per Package

10

Contains DI Package

00814639025118

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton