Emprint - Procedure Planning Application - Covidien LP

Duns Number:058614483

Device Description: Procedure Planning Application

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More Product Details

Catalog Number

-

Brand Name

Emprint

Version/Model Number

CAMPP

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 04, 2019

Issuing Agency

In GS1

Product Characteristics

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

K142048

Product Code Details

Product Code

LLZ

Product Code Name

System, image processing, radiological

Device Record Status

Public Device Record Key

8abcdc5f-4ee8-4824-9c5b-b3a24fea8d0b

Public Version Date

April 08, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"COVIDIEN LP" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 132
2 A medical device with a moderate to high risk that requires special controls. 8540
3 A medical device with high risk that requires premarket approval 202
U Unclassified 40