Catalog Number

111989

Brand Name

Premium Plus CEEA

Version/Model Number

111989

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K001895,K001895

Product Code

GDW

Product Code Name

STAPLE, IMPLANTABLE

Public Device Record Key

6a55649c-b38e-4060-bcc9-51a5620513a0

Public Version Date

September 09, 2019

Public Version Number

6

DI Record Publish Date

August 28, 2015

Package DI Number

20884523006619

Quantity per Package

3

Contains DI Package

10884523006612

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE