Duns Number:305524696
Device Description: SpeediCath Compact. Urinary catheter for intermittent catheterization. Ready to use coated SpeediCath Compact. Urinary catheter for intermittent catheterization. Ready to use coated catheter. Nelaton. Female. Not made with natural rubber latex. CH/FR 10/3.3 mm. Rx Only.
Catalog Number
28580
Brand Name
SpeediCath Compact
Version/Model Number
28580
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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"
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
K072808,K072808,K072808,K072808
Product Code
GBM
Product Code Name
CATHETER, URETHRAL
Public Device Record Key
7f1b3a7a-d269-426c-84b6-07fcf4d1ef96
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 27, 2016
Package DI Number
05708932024693
Quantity per Package
5
Contains DI Package
05708932020558
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Sample pack
| 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 |