Catalog Number

A750-BP35

Brand Name

SHARD

Version/Model Number

A750-BP35

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

EME

Product Code Name

Punch, Biopsy, Surgical

Public Device Record Key

b73ca047-0ab4-4be1-b7cd-cfb24804960c

Public Version Date

March 24, 2022

Public Version Number

1

DI Record Publish Date

March 16, 2022

Package DI Number

10814639025160

Quantity per Package

10

Contains DI Package

00814639025163

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton