Self-Cath - Self-Cath Plus. Hydrophilic-coated Soft Straight - Coloplast A/S

Duns Number:305524696

Device Description: Self-Cath Plus. Hydrophilic-coated Soft Straight Tip. Male. FR 12. 16 in. 40 cm. Rx only.

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More Product Details

Catalog Number

50301

Brand Name

Self-Cath

Version/Model Number

50301

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

K003784,K003784,K003784

Product Code Details

Product Code

EZD

Product Code Name

CATHETER, STRAIGHT

Device Record Status

Public Device Record Key

9d17c5a7-ed7e-430e-b91f-0d317fefc4b3

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 02, 2016

Additional Identifiers

Package DI Number

05708932279727

Quantity per Package

12

Contains DI Package

05708932279710

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper box

"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