TROCARTROCAR - FALLER STYLET - Medical Components, Inc.

Duns Number:038000253

Device Description: FALLER STYLET

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More Product Details

Catalog Number

-

Brand Name

TROCARTROCAR

Version/Model Number

FSX

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 29, 2021

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

14ec98ff-ebb2-4de6-bec3-0422affd00c2

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

October 07, 2016

Additional Identifiers

Package DI Number

50884908108199

Quantity per Package

5

Contains DI Package

00884908108194

Package Discontinue Date

January 29, 2021

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