Duns Number:961027315
Device Description: Surgical Reservoir Kit Round 19Fr 400ml With Trocar Silicone
Catalog Number
SU130-1010
Brand Name
JACKSON-PRATT
Version/Model Number
SU130-1010
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
October 30, 2024
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
GCY
Product Code Name
APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
Public Device Record Key
9c8ff3ba-8241-41bf-81d9-6fa01ae5e6a4
Public Version Date
August 03, 2021
Public Version Number
3
DI Record Publish Date
December 21, 2018
Package DI Number
50630140020962
Quantity per Package
10
Contains DI Package
10630140020964
Package Discontinue Date
October 30, 2024
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 | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |