TROCARTROCAR - FOOTBALL TUNNELER - Medical Components, Inc.

Duns Number:038000253

Device Description: FOOTBALL TUNNELER

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More Product Details

Catalog Number

-

Brand Name

TROCARTROCAR

Version/Model Number

FTT10

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 14, 2017

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"

Yes

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 Details

Product Code

DRC

Product Code Name

Trocar

Device Record Status

Public Device Record Key

ea6bebad-c84d-4b54-affa-9f549b68d3a9

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 21, 2016

Additional Identifiers

Package DI Number

50884908016845

Quantity per Package

5

Contains DI Package

00884908016840

Package Discontinue Date

December 14, 2017

Package Status

Not in Commercial Distribution

Package Type

box

"MEDICAL COMPONENTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 31
2 A medical device with a moderate to high risk that requires special controls. 2560