Catalog Number

8000115

Brand Name

Zimmer

Version/Model Number

8000115

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

EGG

Product Code Name

ATTACHMENT, PRECISION, ALL

Public Device Record Key

db02e814-f9bc-47c4-b49b-c41caa8b94b0

Public Version Date

November 01, 2022

Public Version Number

1

DI Record Publish Date

October 24, 2022

Package DI Number

00842092176665

Quantity per Package

10

Contains DI Package

00842092166987

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pack