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Orbit Galaxy Enpower Xtrasoft

FDA UDI

Class II (US FDA UDI)

by Medos International Sàrl

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 2.5mm x 2.5cm 190cm Contents: 1 Detachable Coil System Coil Type: Stretch Resistant Complex XTRASOFT Coil FDA UDI
Model / Reference
641CX2525 FDA UDI
Description
ORBIT GALAXY G2 microcoil Stretch Resistant Complex XTRASOFT Coil 2.5mm x 2.5cm 190cm Contents: 1 Detachable Coil System Coil Type: Stretch Resistant Complex XTRASOFT Coil FDA UDI

Identifiers

Catalog Number
641CX2525 FDA UDI
Primary DI / UDI-DI
10878528008900 FDA UDI
510(k) Number
K142429 FDA UDI
FDA Product Code
HCG FDA UDI
KRD FDA UDI
GMDN Term
Neurovascular embolization coil FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5950 FDA UDI
870.3300 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 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

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Manufacturer

Manufacturer
Medos International Sàrl

Sources (1)

  • FDA UDI 56af3edd-df03-4ae3-974b-02b632be3d1d 38 fields · synced Jun 1, 2026