Duns Number:006261481
Device Description: TUBING 3502 10PK 3/8 X 3/32 X 2FT
Catalog Number
-
Brand Name
Intersept®
Version/Model Number
3502
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 13, 2018
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K800178,K800178
Product Code
KNX
Product Code Name
COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER
Public Device Record Key
03b9804d-bc88-46aa-bf8a-0e307a6485fc
Public Version Date
December 11, 2018
Public Version Number
4
DI Record Publish Date
May 28, 2016
Package DI Number
20681490007751
Quantity per Package
10
Contains DI Package
00673978573137
Package Discontinue Date
April 13, 2018
Package Status
Not in Commercial Distribution
Package Type
PK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |