Duns Number:482661753
Device Description: ORBIT GALAXY G2 microcoil Stretch Resistant Complex Fill Coil 3.5mm x 9cm 190cm Contents: ORBIT GALAXY G2 microcoil Stretch Resistant Complex Fill Coil 3.5mm x 9cm 190cm Contents: 1 Detachable Coil System Coil Type: Stretch Resistant Complex Fill Coil
Catalog Number
641CF3509
Brand Name
ORBIT GALAXY ENPOWER
Version/Model Number
641CF3509
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
K142429
Product Code
HCG
Product Code Name
DEVICE, NEUROVASCULAR EMBOLIZATION
Public Device Record Key
9fe31679-0adb-4eaa-a5cd-5fc683637c62
Public Version Date
February 05, 2021
Public Version Number
4
DI Record Publish Date
September 20, 2015
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 | 972 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6382 |
| 3 | A medical device with high risk that requires premarket approval | 20 |
| U | Unclassified | 20 |