FDA UDI
In Commercial Distribution
🇺🇸 United States
Action®
DI: 00089904000064
·
Model: Bolx I
·
ACTION PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Action®
- Primary DI
- 00089904000064
- Version / Model
- Bolx I
- Catalog Number
- 31052
- Company Name
- ACTION PRODUCTS, INC.
- Labeler DUNS
- 067543058
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-21
- Public Version
- 3
- Public Version Date
- 2021-03-24
- Public Version Status
- Update
- Public Device Record Key
- ae3b4936-8352-48b5-bd47-3ac6f538b322
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- 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 |
|---|---|---|---|---|
| JAD | System, Therapeutic, X-Ray | Radiology | 892.5900 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58022 | Radiation therapy bolus, reusable | 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 reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00089904000064 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K811528 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store flat
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a clean, dry environment
- Type
- Special Storage Condition, Specify
- Special Conditions
- Minimal UV light exposure