Catalog Number

PER 11-14-SG

Brand Name

Meridian Perforator

Version/Model Number

alpha

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

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

K121253

Product Code

HBF

Product Code Name

Drills, Burrs, Trephines & Accessories (Compound, Powered)

Public Device Record Key

d7139318-00fb-44fb-97c1-0cd036311b83

Public Version Date

November 22, 2018

Public Version Number

4

DI Record Publish Date

February 11, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-