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 with Tight Distal Loop Technology 4mm x 8cm 190cm Contents: 1 Detachable Coil System Coil Type: Stretch Resistant Complex XTRASOFT Coil with Tight Distal Loop Technology FDA UDI
Model / Reference: 641CX0408 FDA UDI
Description: ORBIT GALAXY G2 microcoil Stretch Resistant Complex XTRASOFT Coil with Tight Distal Loop Technology 4mm x 8cm 190cm Contents: 1 Detachable Coil System Coil Type: Stretch Resistant Complex XTRASOFT Coil with Tight Distal Loop Technology FDA UDI

Identifiers

Catalog Number: 641CX0408 FDA UDI
Primary DI / UDI-DI: 10878528009372 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

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

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

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Medos International Sàrl

Sources (1)

FDA UDI 83837b9c-49d9-4dbb-9020-09ebde157369 38 fields · synced May 31, 2026