Vein Irrigation Cannula DMC VIC Sterile - Vein Irrigation Cannula Sterile - DMC MEDICAL LIMITED

Duns Number:989772017

Device Description: Vein Irrigation Cannula Sterile

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More Product Details

Catalog Number

FD-1006

Brand Name

Vein Irrigation Cannula DMC VIC Sterile

Version/Model Number

DMC VIC STERILE

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K000704,K000704,K000704

Product Code Details

Product Code

GBX

Product Code Name

Catheter, Irrigation

Device Record Status

Public Device Record Key

9c6b172e-3d6b-4ab2-a8ee-bf2d9a3161d6

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 10, 2016

Additional Identifiers

Package DI Number

05391530750110

Quantity per Package

21

Contains DI Package

05391530750103

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"DMC MEDICAL LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 29