Duns Number:327681359
Device Description: Appl.forc.Yasargil STANARD Titanium Clip, 110mm bayonet shaft, with Memory-Effect, rotatin Appl.forc.Yasargil STANARD Titanium Clip, 110mm bayonet shaft, with Memory-Effect, rotating titan. jaw, round handle
Catalog Number
65.8211 TI
Brand Name
LAZIC
Version/Model Number
65.8211 TI
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
7542a68d-6931-4ab7-8518-62567dcc6185
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
May 04, 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 |