Porges Coloplast - ImaJin™ Silicone hydro-coated Double loop - Coloplast A/S

Duns Number:305524696

Device Description: ImaJin™ Silicone hydro-coated Double loop ureteral stent open/open CH FR 08 length 30cm wi ImaJin™ Silicone hydro-coated Double loop ureteral stent open/open CH FR 08 length 30cm with steerable pusher CH FR 08 and Orchestra™ guidewire

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More Product Details

Catalog Number

BCHS86

Brand Name

Porges Coloplast

Version/Model Number

BCHS86

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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

K180469

Product Code Details

Product Code

FAD

Product Code Name

STENT, URETERAL

Device Record Status

Public Device Record Key

bd7d8625-73bd-4ea4-8d89-6759c9cb38a3

Public Version Date

April 08, 2019

Public Version Number

1

DI Record Publish Date

March 29, 2019

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