FDA UDI
In Commercial Distribution
🇺🇸 United States
BodyFIX
DI: 04056719000028
·
Model: P10102-102
·
3C-Medical Intelligence GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BodyFIX
- Primary DI
- 04056719000028
- Version / Model
- P10102-102
- Catalog Number
- P10102-102
- 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
- b38426cd-ba7f-420c-b414-cb389c0029c4
Device Description
BodyFIX® Comfort Module 500x400mm is a cushion to place the head and upper body comfortably on the couchtop where no BlueBAG is beyond the patient’s body.
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
- No
- 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 |
|---|---|---|---|---|
| IYE | Accelerator, Linear, Medical | Radiology | 892.5050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40895 | Vacuum-mould patient positioning system | An assembly of devices designed to apply a vacuum to a cushion or bag filled with foam-like material that is placed under, on, or around a patients body parts. A vacuum is applied to the contents of the cushion forming a patient specific (custom-made) mould. The moulds can be whole body or selected body parts and help ensure adequate positioning and immobilization of the patient during diagnostic imaging and/or radiation therapy procedures facilitating reproducible positioning for serial procedures. This system typically includes reusable foam-filled bags, cushions, a vacuum unit, hardware, seals, and interfaces used to connect the mould to another patient positioning system (PPS). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04056719000028 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K121530 | 000 |