Duns Number:080478537
Device Description: CLEAR FLUSH SLIDE LOCK PRESTIGE TYPE GRASPER NON ROT SING ACTION 5MM 45CM
Catalog Number
-
Brand Name
AIM CLEAR FLUSH
Version/Model Number
A1-1226SL
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
b9d29ec8-61b9-4e39-89c9-991bd4bc3799
Public Version Date
August 21, 2019
Public Version Number
4
DI Record Publish Date
March 13, 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 |