Duns Number:809784593
Device Description: ABVISER AV IAP W/EDW'DS T'DUCER, PATIENT
Catalog Number
420756
Brand Name
ABVISER
Version/Model Number
420756
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 20, 2022
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"
-
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
FEN
Product Code Name
Device, Cystometric, Hydraulic
Public Device Record Key
0fc97299-c9d4-4cfc-a7f9-e15c44eb8272
Public Version Date
May 23, 2022
Public Version Number
3
DI Record Publish Date
September 01, 2016
Package DI Number
00768455128099
Quantity per Package
10
Contains DI Package
00768455127955
Package Discontinue Date
May 20, 2022
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 116 |
| U | Unclassified | 8 |