Duns Number:327681359
Device Description: Appl.forceps for Yasargil STANDARD Clips, 180mm rigid shaft 360°rotating,rigid, ring handl Appl.forceps for Yasargil STANDARD Clips, 180mm rigid shaft 360°rotating,rigid, ring handle
Catalog Number
65.530
Brand Name
LAZIC
Version/Model Number
65.530
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HCI
Product Code Name
Applier, Aneurysm Clip
Public Device Record Key
becb622c-b4b3-4b49-9013-f7c8f60134c5
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
May 03, 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 | 1084 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1125 |