Duns Number:305524696
Device Description: SpeediCath Compact Set. Urinary catheter with attached bag for intermittent catheterizatio SpeediCath Compact Set. Urinary catheter with attached bag for intermittent catheterization. Ready to use coated catheter. Nelaton. Female. Length: 3.5 in, Vol 750 ml. FR 14/4.4 mm. Rx only.
Catalog Number
28524
Brand Name
SpeediCath Compact
Version/Model Number
28524
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"
-
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
K121457,K121457,K121457,K121457
Product Code
GBM
Product Code Name
CATHETER, URETHRAL
Public Device Record Key
81e0434d-aca8-4ccb-bcc3-b157d36080e9
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 02, 2016
Package DI Number
05708932543965
Quantity per Package
20
Contains DI Package
05708932543958
Package Discontinue Date
-
Package Status
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 |