Catalog Number

1750-0040

Brand Name

Pisces-SA

Version/Model Number

1750-0040

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

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

K213935

Product Code

HWJ

Product Code Name

Awl

Public Device Record Key

b54c6a76-c005-4902-a864-66640453cf76

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

May 24, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-