Duns Number:305524696
Device Description: EASIVAC® / System for collecting pieces of tissue after TURP / Connector - ACMI
Catalog Number
E80403
Brand Name
Porges Coloplast
Version/Model Number
E80403
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
FFD
Product Code Name
EVACUATOR, BLADDER, MANUALLY OPERATED
Public Device Record Key
bbab0630-591d-4f37-adc5-7e78ef77f13a
Public Version Date
April 29, 2019
Public Version Number
1
DI Record Publish Date
April 20, 2019
Package DI Number
05708932705455
Quantity per Package
20
Contains DI Package
05705243322197
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Retail box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 46 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 899 |
| 3 | A medical device with high risk that requires premarket approval | 72 |
| U | Unclassified | 7 |