FDA UDI
In Commercial Distribution
🇺🇸 United States
.decimal Proton Range Compensator
DI: 00851147007014
·
Model: 2.8
·
DECIMAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- .decimal Proton Range Compensator
- Primary DI
- 00851147007014
- Version / Model
- 2.8
- Company Name
- DECIMAL, INC.
- Labeler DUNS
- 617041967
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 4edf1802-6416-4f75-b9ec-244fefa5db2d
- Distribution End Date
- 9999-12-31
Device Description
Custom manufactured solid Range Compensators for intensity modulation of external beam proton radiation therapy.
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
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| IXI | Block, Beam-Shaping, Radiation Therapy | Radiology | 892.5710 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42274 | Radiation therapy beam block material | A material designed for creating a custom-made beam block used to size, shape, or control depth of penetration of a beam of radiation delivered to a patient during radiation therapy treatments, to limit or eliminate exposure to non-target body areas. Beam block material is either: 1) a highly attenuating material, e.g., lead, cerrobend (Wood’s metal), or Rose's metal (aperture type); or 2) a material such as acrylic or wax that can be used to control the beam energy delivery depth. It can be cut or moulded into specific configurations to shape/define/attenuate the radiation beam, and is typically remelted for reuse after the patient treatment is considered finished. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851147007014 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K071078 | 000 |