Duns Number:055870299
Device Description: Carbon Fiber Handlefor Modular Instrument Inserts, rotatable,w/ratchet w/HF-connection
Catalog Number
-
Brand Name
ASSI
Version/Model Number
ASSI.AEP87326R
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
-
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
353d2256-32c0-49af-9f19-f887768d94c7
Public Version Date
August 09, 2018
Public Version Number
3
DI Record Publish Date
September 26, 2016
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 | 1975 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 400 |