Porges Coloplast - DORMIA® Stone extractors with an "extractible - Coloplast A/S

Duns Number:305524696

Device Description: DORMIA® Stone extractors with an "extractible basket"

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More Product Details

Catalog Number

EFP624

Brand Name

Porges Coloplast

Version/Model Number

EFP624

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

FFL

Product Code Name

DISLODGER, STONE, BASKET, URETERAL, METAL

Device Record Status

Public Device Record Key

1f6e3b97-d5c0-45ce-9233-a6412dab7327

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 01, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"COLOPLAST A/S" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 46
2 A medical device with a moderate to high risk that requires special controls. 899
3 A medical device with high risk that requires premarket approval 72
U Unclassified 7