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Orbit Galaxy Enpower

FDA UDI

Class II (US FDA UDI)

by Medos International Sàrl

Identity

Trade Name
ORBIT GALAXY ENPOWER FDA UDI
Generic Name
Neurovascular embolization coil FDA UDI
Device Name
ORBIT GALAXY G2 microcoil Stretch Resistant Complex Fill Coil with Tight Distal Loop Technology 5mm x 10cm 190cm Contents: 1 Detachable Coil System Coil Type: Stretch Resistant Complex Fill Coil with Tight Distal Loop Technology FDA UDI
Model / Reference
641CF0510 FDA UDI
Description
ORBIT GALAXY G2 microcoil Stretch Resistant Complex Fill Coil with Tight Distal Loop Technology 5mm x 10cm 190cm Contents: 1 Detachable Coil System Coil Type: Stretch Resistant Complex Fill Coil with Tight Distal Loop Technology FDA UDI

Identifiers

Catalog Number
641CF0510 FDA UDI
Primary DI / UDI-DI
10878528009563 FDA UDI
510(k) Number
K142429 FDA UDI
FDA Product Code
KRD FDA UDI
HCG FDA UDI
GMDN Term
Neurovascular embolization coil FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.3300 FDA UDI
882.5950 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
MRI Safety
MR Conditional FDA UDI

Orbit Galaxy Enpower 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

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Manufacturer

Manufacturer
Medos International Sàrl

Sources (1)

  • FDA UDI 1cf3a892-5760-4f2b-af24-33c6568480ba 38 fields · synced Jun 1, 2026