FDA UDI
In Commercial Distribution
🇺🇸 United States
GliaSite® Catheter Tray
DI: M74810200
·
Model: 1020
·
ISORAY MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- GliaSite® Catheter Tray
- Primary DI
- M74810200
- Version / Model
- 1020
- Company Name
- ISORAY MEDICAL, INC.
- Labeler DUNS
- 113577485
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-28
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- f7662f4b-f1f6-4da6-bda6-af5078c2b3bd
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KXK | Source, Brachytherapy, Radionuclide | Radiology | 892.5730 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38412 | Brain brachytherapy system applicator, manual | A device specifically designed to be used in radiation therapy treatments of the brain. It has individual or modular device configurations designed to facilitate manual placement, e.g., puncture, endoscopically guided placement or diagnostic imaging guided placement, and removal of single or multiple radioactive sources at a treatment site within the brain. The device may be a fixed design or designed to accommodate individual patient source placement configurations and includes brain applicators such as hollow needles, tubes or catheters, used in manual brachytherapy applications. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M74810200 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K111931 | 000 |