Kii® Fios® Dual Pack - Laparoscopic Trocar Sleeve/Single Use - APPLIED MEDICAL RESOURCES CORPORATION

Duns Number:187129135

Device Description: Laparoscopic Trocar Sleeve/Single Use

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More Product Details

Catalog Number

-

Brand Name

Kii® Fios® Dual Pack

Version/Model Number

CTF75

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

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Device Record Status

Public Device Record Key

2a00cda3-c3fa-4899-9815-1efcadfe7df5

Public Version Date

January 09, 2020

Public Version Number

3

DI Record Publish Date

August 26, 2016

Additional Identifiers

Package DI Number

10607915129900

Quantity per Package

10

Contains DI Package

00607915129903

Package Discontinue Date

-

Package Status

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