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, X-Ray Opaque
Catalog Number
0071360
Brand Name
Closed Wound Suction
Version/Model Number
0071360
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
b71417ee-8512-41b2-9e96-4e32728d9124
Public Version Date
September 30, 2020
Public Version Number
1
DI Record Publish Date
September 22, 2020
Package DI Number
20801741049648
Quantity per Package
2
Contains DI Package
10801741049641
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 |