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. Female. FR 8/2.7 mm. Rx only.
Catalog Number
28508
Brand Name
SpeediCath
Version/Model Number
28508
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
-
Product Code
GBM
Product Code Name
CATHETER, URETHRAL
Public Device Record Key
e549149c-0a21-44e7-8281-0ef202ce4130
Public Version Date
January 24, 2019
Public Version Number
4
DI Record Publish Date
September 02, 2016
Package DI Number
05708932641111
Quantity per Package
10
Contains DI Package
05708932641104
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper 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 |