Duns Number:196548481
Device Description: 11cm iQ Knife
Catalog Number
5500-25B-107
Brand Name
Sonopet iQ
Version/Model Number
550025B107
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
LFL
Product Code Name
Instrument, ultrasonic surgical
Public Device Record Key
a75f7c21-7990-4259-a95c-dd1d12c253c9
Public Version Date
February 22, 2022
Public Version Number
2
DI Record Publish Date
May 02, 2019
Package DI Number
37613327422482
Quantity per Package
4
Contains DI Package
07613327422481
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
pack
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2188 |
2 | A medical device with a moderate to high risk that requires special controls. | 3183 |
U | Unclassified | 60 |