Duns Number:191077671
Device Description: Ruby Coil LP, 4mm x 8cm
Catalog Number
-
Brand Name
LP Coil System
Version/Model Number
RBYLP0408
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K192955
Product Code
HCG
Product Code Name
DEVICE, NEUROVASCULAR EMBOLIZATION
Public Device Record Key
f56b7fa5-10dd-4135-934c-f81cd781353c
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
January 21, 2020
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 918 |
U | Unclassified | 1 |