FDA UDI
In Commercial Distribution
🇺🇸 United States
Advantage I-125®
DI: M936IEPS9
·
Model: IEPS
·
ISOAID, L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
9
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Basic Information
- Brand Name
- Advantage I-125®
- Primary DI
- M936IEPS9
- Version / Model
- IEPS
- Company Name
- ISOAID, L.L.C.
- Labeler DUNS
- 002751241
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 9
- Record Status
- Published
- Publish Date
- 2016-02-04
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- e2217c2c-8d14-4c29-a8fc-f96954727b57
Device Description
Advantage I-125® radioactive seeds with a molded form that is shielded on one side and contains grooved positions for manual brachytherapy sources on the other side and is used for the temporary topical application of brachytherapy sources to the surface of the eye.
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
- MR Conditional
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide, Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KXK | Source, Brachytherapy, Radionuclide | Radiology | 892.5730 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38434 | Eye brachytherapy system applicator, manual | A device in the form of a template that is shielded on one side and containing grooved positions for manual brachytherapy sources on the other used for the temporary topical application of brachytherapy sources to the surface of the eye. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M936IEPS9 | HIBCC | ||||
| Unit of Use | M936IEPS | HIBCC |