Catalog Number

SFT-1000

Brand Name

SoftBiopsy

Version/Model Number

SFT-1000

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GEE

Product Code Name

Brush, Biopsy, General & Plastic Surgery

Public Device Record Key

b81e7db9-14be-451e-84ee-ffa9bcdc9cf6

Public Version Date

July 19, 2021

Public Version Number

2

DI Record Publish Date

November 10, 2019

Package DI Number

10860275000313

Quantity per Package

250

Contains DI Package

00860275000316

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case