FDA UDI
In Commercial Distribution
🇺🇸 United States
Connexion
DI: 04056719001186
·
Model: P10105-200
·
3C-Medical Intelligence GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Connexion
- Primary DI
- 04056719001186
- Version / Model
- P10105-200
- Catalog Number
- P10105-200
- Company Name
- 3C-Medical Intelligence GmbH
- Labeler DUNS
- 314546664
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-23
- Public Version
- 4
- Public Version Date
- 2023-12-15
- Public Version Status
- Update
- Public Device Record Key
- 7ca3bac7-40ba-493c-95f9-2cba82919957
Device Description
The Connexion™ modular couchtop consists of a Base Board that attaches to the Precise Table and several modules which can be attached (and detached) to the Base Board. Each of the different modules is designed to fulfill specific treatment scenarios.
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
- Yes
- 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 |
|---|---|---|---|---|
| IXQ | Table, Radiographic, Stationary Top | Radiology | 892.1980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40686 | Accelerator system table, non-powered | A non-electrical radiotherapy device that is a component of an accelerator system specifically designed to position and support a patient, typically supine, during therapeutic radiation treatments administered using a medical linear accelerator or non-linear accelerator. It is a flat surface on legs with fixed position top or mechanical top positioning and/or height controls (e.g., pneumatic controls, magnetic locks, cranks and lever mechanisms). It may be an independent device that is stationary or mobile, or it can be an integral component of a medical accelerator system design. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04056719001186 | GS1 |