Duns Number:054765780
Device Description: The CompactCath Intermitten Urinary Catheter is a sterile, single use urine drainage cathe The CompactCath Intermitten Urinary Catheter is a sterile, single use urine drainage catheter for use in draining urine from the bladder in subjects with urine drainage problems.
Catalog Number
N1612
Brand Name
COMPACTCATH
Version/Model Number
40788
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
-
Product Code
EZD
Product Code Name
Catheter, Straight
Public Device Record Key
1c4fe563-b78d-411b-8447-657c8186ab57
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
April 20, 2017
Package DI Number
00852141007017
Quantity per Package
30
Contains DI Package
00852141007000
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |