Identity
- Trade Name
- LANDANGER FDA UDI
- Generic Name
- Surgical instrument assist arm system, power-adjusted FDA UDI
- Model / Reference
- E320010POM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03661219259381 FDA UDI
- FDA Product Code
- DWS FDA UDI
- GMDN Term
- Surgical instrument assist arm system, power-adjusted FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 870.4500 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical instrument assist arm system, power-adjusted
Landanger by Landanger — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical instrument assist arm system, power-adjusted.
- Micro Manipulator PSMP — MITAKA KOHKI CO., LTD. · Class II
- VITOM — Karl Storz GmbH & Co. KG · Class I
- Universal Adapter 10-15mm — MITAKA KOHKI CO., LTD. · Class II
- POINT SETTER — Karl Storz GmbH & Co. KG · Class I
- Cirq Arm System 2.0 — Brainlab SE · Class II
- VIKY — Endocontrol · Class II
- VIKY — Endocontrol · Class II
- VIKY — Endocontrol · Class II
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 I | Pending data |
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Manufacturer
- Manufacturer
- Landanger
Sources (1)
- FDA UDI 7a32ccef-e7b2-43a1-9d5f-ab1b8e699d3d 32 fields · synced May 30, 2026