FDA UDI
In Commercial Distribution
🇺🇸 United States
BodyFIX
DI: 04056719000233
·
Model: P10102-302
·
3C-Medical Intelligence GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- BodyFIX
- Primary DI
- 04056719000233
- Version / Model
- P10102-302
- Catalog Number
- P10102-302
- Company Name
- 3C-Medical Intelligence GmbH
- Labeler DUNS
- 314546664
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- 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
- b090174e-044f-41e2-8c05-909119779137
Device Description
BodyFIX® Cover Sheet THORAX 1800x1600mm with sleeve includes five cover sheets. The cover sheets are placed over the patient to generate the vacuum. This set is used for the BodyFIX 14 BlueBAG THORAX.
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 | 04056719000233 | GS1 | ||||
| Unit of Use | 04056719001889 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K121530 | 000 |