Duns Number:305524696
Device Description: SpeediCath Standard. Catheter with accessories. Nelaton. Female. 1 Ready to use coated cat SpeediCath Standard. Catheter with accessories. Nelaton. Female. 1 Ready to use coated catheter, sterilized using irradiation. FR 10/3.3 mm. 1 Water proof drape, sterilized using ethylene oxide. 2 Non-sterile, non-latex gloves, 2 Non-sterile iodine pads, 1 Non-sterile urine bag, 700 ml. Rx only.
Catalog Number
28501
Brand Name
SpeediCath
Version/Model Number
28501
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
9c984301-58a5-4070-b241-1fbd35cd7c42
Public Version Date
April 02, 2020
Public Version Number
1
DI Record Publish Date
March 25, 2020
Package DI Number
05701780209281
Quantity per Package
100
Contains DI Package
05701780209113
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 |