Duns Number:305524696
Device Description: SpeediCath Compact Eve. Sterile urinary catheter for intermittent use. Female ready-to-use SpeediCath Compact Eve. Sterile urinary catheter for intermittent use. Female ready-to-use coated catheter. Length 3.25 in. FR 14/4.7 mm. Rx only.
Catalog Number
28114
Brand Name
SpeediCath Compact
Version/Model Number
28114
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 01, 2017
Issuing Agency
In GS1
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"
-
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
GBM
Product Code Name
CATHETER, URETHRAL
Public Device Record Key
a54c7a53-9f12-4061-ae33-123c86521a6a
Public Version Date
April 13, 2018
Public Version Number
3
DI Record Publish Date
September 02, 2016
Package DI Number
05708932618755
Quantity per Package
30
Contains DI Package
05708932618779
Package Discontinue Date
December 01, 2017
Package Status
Not in Commercial Distribution
Package Type
Retail box
| 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 |