FDA UDI
In Commercial Distribution
🇺🇸 United States
Clearsight Bolus
DI: 10850020486004
·
Model: B-03-18-01
·
CLEARSIGHT RT LLC
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
3
Basic Information
- Brand Name
- Clearsight Bolus
- Primary DI
- 10850020486004
- Version / Model
- B-03-18-01
- Company Name
- CLEARSIGHT RT LLC
- Labeler DUNS
- 117523635
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2022-05-13
- Public Version
- 1
- Public Version Date
- 2022-05-23
- Public Version Status
- New
- Public Device Record Key
- aa35956d-24ca-4bdb-9e1b-65f0cfb8081f
Device Description
Clearsight Bolus, 0.3cm water equivalent thickness, 0.34cm physical thickness, Clear, 30cm x 30cm, (3) units per package
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
- Yes
- 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 |
|---|---|---|---|---|
| IYP | Phantom, Anthropomorphic, Nuclear | Radiology | 892.1370 | 1 |
| IXG | Phantom, Anthropomorphic, Radiographic | Radiology | 892.1950 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58021 | Radiation therapy bolus, single-use | A pliable, solid, non-sterile material (e.g., firm gel, paraffin, silicone) that has the properties of skin when irradiated and is intended to be applied to the skin to modify radiation dose at the skin surface or depth. It is available in various static thicknesses (e.g., 0.5 to 4.0 cm), which may be cut by the operator, to provide a reproducible radiation beam modifier for a prescribed dose depth during treatment of a particular site and disease. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00850020486007 | GS1 | ||||
| Primary | 10850020486004 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 30 | Centimeter | |
| Width | 30 | Centimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store flat (not folded) in original packaging in a cool, dry environment.