Catalog Number

71279424

Brand Name

BUCK

Version/Model Number

71279424

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

K791125,K791125

Product Code

LZN

Product Code Name

CEMENT OBTURATOR

Public Device Record Key

245beab4-1089-4cfc-a515-c6a934087ec7

Public Version Date

November 03, 2020

Public Version Number

5

DI Record Publish Date

August 29, 2015

Package DI Number

23596010493624

Quantity per Package

3

Contains DI Package

03596010493620

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX