FDA UDI
In Commercial Distribution
🇺🇸 United States
Advantage I-125®
DI: M936IMLN9
·
Model: IMLN
·
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
- M936IMLN9
- Version / Model
- IMLN
- 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
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 8775723b-29b4-4e2c-b591-b12cf1bfad6f
Device Description
Advantage I-125® radioactive seeds, Cartridge-load, non-sterile
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 Safe
- 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
- No
- 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 |
|---|---|---|---|---|
| 38299 | Manual brachytherapy system | An assembly of therapeutic, independent devices, manually brought together and intended to deliver a palliative or therapeutic radiation dose to an anatomical region from radionuclide sources. Medical personnel manually place multiple radioactive sources in appliances and applicators for either permanent or temporary delivery at the topical, interstitial, intraluminal, or intracavitary brachytherapy treatment site. The radioactive source(s) assemblies contain naturally occurring, reactor produced, or accelerator produced radionuclides that are in the form of, e.g., encapsulated, embedded, sealed, wire, plated or foil sources, contained radioactive liquids, gels or gas. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M936IMLN9 | HIBCC | ||||
| Unit of Use | M936IMLN | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K011205 | 000 |