SpeediCath - SpeediCath Standard. Urinary catheter for - Coloplast A/S

Duns Number:305524696

Device Description: SpeediCath Standard. Urinary catheter for intermittent catheterization. Ready to use coate SpeediCath Standard. Urinary catheter for intermittent catheterization. Ready to use coated catheter. Nelaton. Boy. FR 8/2.7 mm. Rx only.

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More Product Details

Catalog Number

28608

Brand Name

SpeediCath

Version/Model Number

28608

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

GBM

Product Code Name

CATHETER, URETHRAL

Device Record Status

Public Device Record Key

1ffab90c-4878-45e7-85cd-5b64897fa921

Public Version Date

January 24, 2019

Public Version Number

4

DI Record Publish Date

September 02, 2016

Additional Identifiers

Package DI Number

05708932545617

Quantity per Package

30

Contains DI Package

05708932545600

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Retail 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