Duns Number:080478537
Device Description: AIM CLEAR FLUSH DOLPHIN DISSECTOR 5MM 35 CM ROTO MONOPOLAR
Catalog Number
-
Brand Name
AIM CLEAR FLUSH
Version/Model Number
A1-1035
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 20, 2018
Issuing Agency
In HIBCC
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GCJ
Product Code Name
Laparoscope, General & Plastic Surgery
Public Device Record Key
ac0e8ec2-45a7-4faa-80e8-4ef499c7fed5
Public Version Date
March 08, 2019
Public Version Number
3
DI Record Publish Date
June 12, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 7 |
2 | A medical device with a moderate to high risk that requires special controls. | 181 |