M-Drain - The Percutaneous Introducer is used to dilate for - Mermaid Medical A/S

Duns Number:308951313

Device Description: The Percutaneous Introducer is used to dilate for placement of a .035” or .038” guide wire The Percutaneous Introducer is used to dilate for placement of a .035” or .038” guide wire where the puncture is performed with a 21G needle (fine needle).

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More Product Details

Catalog Number

D20106020

Brand Name

M-Drain

Version/Model Number

D20106020

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"

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

K071330,K071330

Product Code Details

Product Code

DRE

Product Code Name

Dilator, Vessel, For Percutaneous Catheterization

Device Record Status

Public Device Record Key

8694bf10-175f-4537-bce7-e32cfe02be0e

Public Version Date

October 10, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

05711055001793

Quantity per Package

5

Contains DI Package

15711055001790

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Retail Box

"MERMAID MEDICAL A/S" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 90
2 A medical device with a moderate to high risk that requires special controls. 152