Duns Number:531408342
Device Description: The Suction Reservoir Kit is designed to be used with the Subdural Drainage Catheter. The The Suction Reservoir Kit is designed to be used with the Subdural Drainage Catheter. The kit contains an extension line and a Suction Reservoir (capacity 100 cc, graduations in 25 cc increments).
Catalog Number
-
Brand Name
Integra®
Version/Model Number
910500
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
GCY
Product Code Name
APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
Public Device Record Key
98fd1943-87b6-472e-a415-0348b2eeecbd
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 08, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 197 |