Duns Number:106712748
Catalog Number
-
Brand Name
Level 1
Version/Model Number
FC400-16
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
K873448,K873448,K873448
Product Code
KOD
Product Code Name
CATHETER, UROLOGICAL
Public Device Record Key
eefd7af9-ba5f-40db-a605-122b65c3ee8d
Public Version Date
December 04, 2020
Public Version Number
10
DI Record Publish Date
October 14, 2016
Package DI Number
35019517061820
Quantity per Package
10
Contains DI Package
30695085000505
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 686 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 1 |