Identity
- Trade Name
- ORBIT GALAXY ENPOWER XTRASOFT FDA UDI
- Generic Name
- Neurovascular embolization coil FDA UDI
- Device Name
- ORBIT GALAXY G2 microcoil Stretch Resistant Complex XTRASOFT Coil 3mm x 4cm 190cm Contents: 1 Detachable Coil System Coil Type: Stretch Resistant Complex XTRASOFT Coil FDA UDI
- Model / Reference
- 641CX0304 FDA UDI
- Description
- ORBIT GALAXY G2 microcoil Stretch Resistant Complex XTRASOFT Coil 3mm x 4cm 190cm Contents: 1 Detachable Coil System Coil Type: Stretch Resistant Complex XTRASOFT Coil FDA UDI
Identifiers
- Catalog Number
- 641CX0304 FDA UDI
- Primary DI / UDI-DI
- 10878528008924 FDA UDI
- 510(k) Number
- K142429 FDA UDI
- FDA Product Code
- KRD FDA UDIHCG FDA UDI
- GMDN Term
- Neurovascular embolization coil FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.3300 FDA UDI882.5950 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Orbit Galaxy Enpower Xtrasoft by Medos International Sàrl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medos International Sàrl
Sources (1)
- FDA UDI 2ffd33cd-d924-4358-aff7-6edb29321b71 38 fields · synced Jun 1, 2026