Identity
- Trade Name
- SOLOASSIST II Set FDA UDI
- Generic Name
- Surgical camera holder FDA UDI
- Device Name
- Set consisting of - 1x Power supply with power cord US (172035 + 172054) - 1x Supply cable (172054) - 1x SOLOASSIST II (141364) - 1x Trolley (120874) - 1x Operating Instruction FDA UDI
- Model / Reference
- 171910 FDA UDI
- Description
- Set consisting of - 1x Power supply with power cord US (172035 + 172054) - 1x Supply cable (172054) - 1x SOLOASSIST II (141364) - 1x Trolley (120874) - 1x Operating Instruction FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260463849103 FDA UDI
- FDA Product Code
- NAY FDA UDI
- GMDN Term
- Surgical camera holder FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical camera holder
SOLOASSIST II Set by Aktormed GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical camera holder.
- TEE Kit — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class I
- Accu-Beam — Transamerican Technologies International · Class I
- Accu-Beam — Transamerican Technologies International · Class I
- Accu-Beam — Transamerican Technologies International · Class I
- Accu-Beam — Transamerican Technologies International · Class I
- Maestro Couplers, 5mm — Moon Surgical, Inc. · Class I
- TEE Kit — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class I
- Accu-Beam — Transamerican Technologies International · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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
- Aktormed GmbH
Sources (2)
- FDA UDI 220892e8-76cc-4cda-9548-b6036f101969 33 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026