Duns Number:016898496
Device Description: CWS 400 Closed Wound Suction Kit, 1/4" (6.3mm, 19Fr.), Silicone Round Drain, with Attached CWS 400 Closed Wound Suction Kit, 1/4" (6.3mm, 19Fr.), Silicone Round Drain, with Attached Trocar, 400cc Evacuator, 3-spring, Y-connecting Tube
Catalog Number
0043670
Brand Name
Closed Wound Suction
Version/Model Number
0043670
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
894c9f8e-c790-4948-9937-e8c104fecdfa
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
September 22, 2020
Package DI Number
20801741049402
Quantity per Package
2
Contains DI Package
10801741049405
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 472 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1994 |
| U | Unclassified | 10 |