FDA UDI
In Commercial Distribution
🇺🇸 United States
External Right
DI: B525FI09C0
·
Model: FI-09C
·
Octostop Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- External Right
- Primary DI
- B525FI09C0
- Version / Model
- FI-09C
- Company Name
- Octostop Inc
- Labeler DUNS
- 240536946
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-11-16
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- f8e98d89-8b29-4239-bbb5-e234ca53f9e7
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
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KPR | System, x-ray, stationary | Radiology | 892.1680 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37692 | X-ray/radiation therapy beam filter, wedge | A wedge-shaped metal filter placed in a beam of primary radiation before it reaches the patient undergoing radiation therapy or imaging procedure. In radiation therapy it ensures uniform irradiation of body areas that vary in thickness or density. In diagnostic imaging it is used to obtain films of a more uniform density when the part being examined diminishes greatly in thickness from one side of the field to the other. It is typically made from aluminium (Al), lead (Pb), copper (Cu), tin (Sn) or combinations of these. Also called compensation filter because when one side of a patient is considerably thicker/denser than the other, the wedge compensates for the physical difference. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B525FI09C0 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K952871 | 000 |