Catalog Number

SFT-4000

Brand Name

Soft K-Bride

Version/Model Number

SFT-4000

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

FZS

Product Code Name

Curette, Surgical, General Use

Public Device Record Key

b145475f-a5ec-40b4-bda4-3c8b62f1714c

Public Version Date

November 18, 2019

Public Version Number

1

DI Record Publish Date

November 10, 2019

Package DI Number

10860275000344

Quantity per Package

250

Contains DI Package

00860275000347

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case