Catalog Number

1760-7072

Brand Name

Pisces-SA

Version/Model Number

1760-7072

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

HTX

Product Code Name

Rongeur

Public Device Record Key

4e9704f6-0f06-45fa-8c72-8689a76e9d16

Public Version Date

May 30, 2022

Public Version Number

1

DI Record Publish Date

May 20, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-