EJ949P - Trocar - APPLIED MEDICAL RESOURCES CORPORATION

Duns Number:187129135

Device Description: Trocar

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More Product Details

Catalog Number

-

Brand Name

EJ949P

Version/Model Number

EJ949P

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 20, 2020

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

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Device Record Status

Public Device Record Key

7d42d2ed-d63c-4b41-b3c0-057ffed412d7

Public Version Date

November 03, 2020

Public Version Number

5

DI Record Publish Date

July 13, 2017

Additional Identifiers

Package DI Number

40386533160076

Quantity per Package

6

Contains DI Package

40386533423416

Package Discontinue Date

August 19, 2019

Package Status

Not in Commercial Distribution

Package Type

-

"APPLIED MEDICAL RESOURCES CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 499
2 A medical device with a moderate to high risk that requires special controls. 698
3 A medical device with high risk that requires premarket approval 1