FDA UDI
In Commercial Distribution
🇺🇸 United States
MIRA Gragoudas Ring
DI: 20850510007457
·
Model: 175
·
MIRA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- MIRA Gragoudas Ring
- Primary DI
- 20850510007457
- Version / Model
- 175
- Catalog Number
- 175
- Company Name
- MIRA, INC.
- Labeler DUNS
- 001414358
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2022-12-13
- Public Version Status
- Update
- Public Device Record Key
- fcbbc05a-7b9f-4edb-9939-1c4d68ba9dca
Device Description
Scleral Marker For Proton Beam Irradiation
Device Characteristics
- Single Use
- Yes
- 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
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HQX | Implant, Orbital, Extra-Ocular | Ophthalmic | 886.3340 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47229 | Proton therapy system beam-delivery system | An integral component of a proton therapy system (PTS) composed of several elements (e.g., a collimator and scattering mechanisms) that permit shaping or scanning of the proton beam, typically using techniques such as double scattering, single scattering, uniform scattering, and pencil beam scattering. It may also include an ionization chamber for dose monitoring and x-ray tubes for the alignment process. This beam delivery system (BDS) is the final portion of a PTS beam management system (BMS) which terminates in the patient treatment room. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 20850510007457 | GS1 | ||||
| Unit of Use | 10850510007450 | GS1 |
Customer Contacts
- Phone
- 5082787877
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K760550 | 000 |