FDA UDI
In Commercial Distribution
🇺🇸 United States
HexaPOD
DI: 04056719001698
·
Model: P10603-100
·
3C-Medical Intelligence GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HexaPOD
- Primary DI
- 04056719001698
- Version / Model
- P10603-100
- Catalog Number
- P10603-100
- 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
- 5
- Public Version Date
- 2023-12-15
- Public Version Status
- Update
- Public Device Record Key
- b3ab27a9-f942-497d-8128-a8640f0a1be5
Device Description
HexaPOD™ evo Module is a robotic couch top which fine adjusts the tumour position to the ISO center
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 |
|---|---|---|---|---|
| JAI | Couch, Radiation Therapy, Powered | Radiology | 892.5770 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40687 | Accelerator system table, powered | An electrically-powered and/or programmable radiotherapy device that is a component of an accelerator system specifically designed to position and support a patient, typically supine, during treatments administered using a medical linear accelerator or non-linear accelerator. It is a flat surface on legs that includes electronic and/or software controls for top height adjustments and positioning. 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 | 04056719001698 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K072898 | 000 |