Duns Number:327681359
Device Description: L-Aneurysm Clip STANDARD, permanent, 15 mm sidewards curved, steril
Catalog Number
S.45.747.15
Brand Name
LAZIC
Version/Model Number
S.45.747.15
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
Yes
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
HCH
Product Code Name
Clip, Aneurysm
Public Device Record Key
a4466cd5-cf31-4cec-be1b-b48956180d00
Public Version Date
February 05, 2021
Public Version Number
4
DI Record Publish Date
December 18, 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 |