NA - THREADED CLEAR CANNULA WITH OBTURATOR 7mm x 75mm - DEPUY MITEK, LLC

Duns Number:190572854

Device Description: THREADED CLEAR CANNULA WITH OBTURATOR 7mm x 75mm

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More Product Details

Catalog Number

214116

Brand Name

NA

Version/Model Number

214116

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

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

GEA

Product Code Name

CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Device Record Status

Public Device Record Key

9b1ec3d6-544e-4f61-ba00-06caa4336d86

Public Version Date

July 22, 2020

Public Version Number

3

DI Record Publish Date

September 01, 2015

Additional Identifiers

Package DI Number

20886705003577

Quantity per Package

5

Contains DI Package

10886705003570

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACKAGE

"DEPUY MITEK, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 560
2 A medical device with a moderate to high risk that requires special controls. 479