M-Catch - Standard Retrieval Net, 3x6cm, 230cm - DIVERSATEK HEALTHCARE, INC.

Duns Number:030650113

Device Description: Standard Retrieval Net, 3x6cm, 230cm

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More Product Details

Catalog Number

1175-01

Brand Name

M-Catch

Version/Model Number

1175-01

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

-

Product Code Details

Product Code

FGX

Product Code Name

Snare, Non-Electrical

Device Record Status

Public Device Record Key

981eec73-f177-41a6-bb4d-16bce845a98a

Public Version Date

April 07, 2021

Public Version Number

3

DI Record Publish Date

August 06, 2018

Additional Identifiers

Package DI Number

10816734021368

Quantity per Package

5

Contains DI Package

00816734021361

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

"DIVERSATEK HEALTHCARE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 109
2 A medical device with a moderate to high risk that requires special controls. 207