Duns Number:016898496
Device Description: 100cc Silicone Closed Wound Suction Evacuator Kit, 100cc Silicone Evacuator with Anti-Refl 100cc Silicone Closed Wound Suction Evacuator Kit, 100cc Silicone Evacuator with Anti-Reflux Valve, Hubless Silicone Flat Drain 7mm Wide, 20cm Long, 3/4 Perforated Drain with Trocar, X-Ray Opaque
Catalog Number
0072360
Brand Name
Closed Wound Suction
Version/Model Number
0072360
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
fe8b26b4-e152-4b99-858a-3633b3318485
Public Version Date
March 08, 2022
Public Version Number
2
DI Record Publish Date
September 22, 2020
Package DI Number
20801741050002
Quantity per Package
2
Contains DI Package
10801741050005
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 |