Catalog Number

4907T

Brand Name

PI

Version/Model Number

4907T

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

K911252,K911252

Product Code

GDW

Product Code Name

STAPLE, IMPLANTABLE

Public Device Record Key

94c96cef-adf1-481e-9e4f-7a2ba76f7ede

Public Version Date

May 07, 2019

Public Version Number

5

DI Record Publish Date

August 28, 2015

Package DI Number

20884521066523

Quantity per Package

6

Contains DI Package

10884521066526

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE