FDA UDI
In Commercial Distribution
🇺🇸 United States
Monarch™ Platform (Refurbished)
DI: B634MON000005R0
·
Model: MON000005R
·
AURIS HEALTH, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Monarch™ Platform (Refurbished)
- Primary DI
- B634MON000005R0
- Version / Model
- MON000005R
- Catalog Number
- MON000005R
- Company Name
- AURIS HEALTH, INC.
- Labeler DUNS
- 015823456
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-10
- Public Version
- 2
- Public Version Date
- 2023-06-19
- Public Version Status
- Update
- Public Device Record Key
- a2075dab-4cbb-448f-b40a-f58efd2a9f7c
Device Description
The Monarch Platform (Refurbished) enables electro-mechanical articulation and precise control of a flexible endoscope (bronchoscope) under continuous and direct control by a physician operator.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | Radiology | 892.1750 | 2 |
| EOQ | Bronchoscope (Flexible Or Rigid) | Ear, Nose, Throat | 874.4680 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38678 | Robotic surgical arm system | An assembly of electromechanical devices designed to be used during computer assisted surgery (CAS) as a functional extension of the surgeon for precise bone and soft-tissue modelling or soft-tissue removal (e.g., during a total knee joint arthroplasty (TKA)). It is computer-based and typically consists of an operator’s console and robotic arms for instrument manipulation. The input to a computer is usually by means of an existing computed tomography (CT) or magnetic resonance imaging (MRI) scan. It can also be used as a training aid for surgeons from a variety of specialities. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B634MON000005R0 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K173760 | 000 |