Catalog Number

-

Brand Name

Primado2

Version/Model Number

P200-SMH-S

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

-

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

K132264,K132264

Product Code

HBC

Product Code Name

MOTOR, DRILL, ELECTRIC

Public Device Record Key

256f3277-b273-4db7-b1e9-47264f0b781c

Public Version Date

March 05, 2021

Public Version Number

2

DI Record Publish Date

January 26, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-