Duns Number:007198742
Catalog Number
-
Brand Name
ACMI Operating Channel Seal 4-5 mm
Version/Model Number
BPS-5
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 27, 2020
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
FAS
Product Code Name
ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
Public Device Record Key
bf66fb99-b31b-4970-a63c-042d0356914c
Public Version Date
October 06, 2022
Public Version Number
2
DI Record Publish Date
September 13, 2018
Package DI Number
00821925008694
Quantity per Package
6
Contains DI Package
00821925038233
Package Discontinue Date
October 27, 2020
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 | 899 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1586 |
| 3 | A medical device with high risk that requires premarket approval | 9 |
| U | Unclassified | 4 |