Identity
- Trade Name
- Archimedes Access Key FDA UDI
- Generic Name
- Virtual bronchoscopic navigation PACS software FDA UDI
- Device Name
- Archimedes Planning Software is software installed on a laptop computer used for planning bronchoscopic procedures. The Planning program provides a planning system to select the region of interest and preview virtual paths to the region of interest through both airways and lung tissue. FDA UDI
- Model / Reference
- 10009-1 FDA UDI
- Description
- Archimedes Planning Software is software installed on a laptop computer used for planning bronchoscopic procedures. The Planning program provides a planning system to select the region of interest and preview virtual paths to the region of interest through both airways and lung tissue. FDA UDI
Identifiers
- Catalog Number
- 10009-1 FDA UDI
- Primary DI / UDI-DI
- 00856571007227 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Virtual bronchoscopic navigation PACS software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 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
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Lot / Batch Number
Yes
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Serial Number
No
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Expiration Date
No
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Manufacturing Date
Yes
FDA UDI
Category: Virtual bronchoscopic navigation PACS software
Archimedes Access Key by Broncus Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Virtual bronchoscopic navigation PACS software.
- LungVision System — Bodyvision Medical , Ltd. · Class II
- LungPoint VBN System, V3.2 — BRONCUS MEDICAL INC. · Class II
- Archimedes Access Key, 10-pack — BRONCUS MEDICAL INC. · Class II
- LungPoint Planning System, v3.2 — BRONCUS MEDICAL INC. · 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 II | Pending data |
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Manufacturer
- Manufacturer
- Broncus Medical Inc.
Sources (1)
- FDA UDI 4eea27b2-6247-4b75-a4b8-572a92107689 36 fields · synced May 31, 2026