Duns Number:007198742
Device Description: ACMI Y-Connector, Luer Lock
Catalog Number
-
Brand Name
ACMI Y-Connector, Luer Lock
Version/Model Number
UBP-Y
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"
-
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
K012758,K012758
Product Code
FGB
Product Code Name
Ureteroscope and accessories, flexible/rigid
Public Device Record Key
2a61076d-9830-4a71-a27d-f8381e79f0a0
Public Version Date
February 21, 2020
Public Version Number
4
DI Record Publish Date
October 18, 2016
Package DI Number
00821925008038
Quantity per Package
6
Contains DI Package
00821925036468
Package Discontinue Date
-
Package Status
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 |