Identity
- Trade Name
- ORBIT GALAXY XTRASOFT FDA UDI
- Generic Name
- Vascular guide-catheter, single-use FDA UDI
- Device Name
- ORBIT GALAXY Detachable Coil System 175cm 2.5mm 3.5cm Contents: 1 detachable coil system and 1 luer valve. Coil Type: Complex Xtrasoft Note: ONLY use with TRUFILL DCS Syringe II FDA UDI
- Model / Reference
- 640CX2535 FDA UDI
- Description
- ORBIT GALAXY Detachable Coil System 175cm 2.5mm 3.5cm Contents: 1 detachable coil system and 1 luer valve. Coil Type: Complex Xtrasoft Note: ONLY use with TRUFILL DCS Syringe II FDA UDI
Identifiers
- Catalog Number
- 640CX2535 FDA UDI
- Primary DI / UDI-DI
- 10886704030676 FDA UDI
- 510(k) Number
- K093973 FDA UDI
- FDA Product Code
- KRD FDA UDIHCG FDA UDI
- GMDN Term
- Vascular guide-catheter, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.3300 FDA UDI882.5950 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Category: Vascular guide-catheter, single-use
Orbit Galaxy Xtrasoft by Medos International Sàrl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Vascular guide-catheter, single-use.
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Cleared under the same submission
K093973 also covers:
- ORBIT GALAXY — Medos International Sàrl
- ORBIT GALAXY — Medos International Sàrl
- ORBIT GALAXY — Medos International Sàrl
- ORBIT GALAXY — Medos International Sàrl
- ORBIT GALAXY — Medos International Sàrl
- ORBIT GALAXY — Medos International Sàrl
- ORBIT GALAXY — Medos International Sàrl
- ORBIT GALAXY — Medos International Sàrl
- ORBIT GALAXY — Medos International Sàrl
- ORBIT GALAXY — Medos International Sàrl
- ORBIT GALAXY — Medos International Sàrl
- ORBIT GALAXY — Medos International Sàrl
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 260aef2a-b86f-436b-91ab-44456d28be96 36 fields · synced Jun 6, 2026