FDA UDI
In Commercial Distribution
🇺🇸 United States
3D-FSD interstitial ovoid pair for 20mm spread with 4 needle guide holes/ovoid
DI: 00816389025578
·
Model: GM11010710
·
VARIAN MEDICAL SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 3D-FSD interstitial ovoid pair for 20mm spread with 4 needle guide holes/ovoid
- Primary DI
- 00816389025578
- Version / Model
- GM11010710
- Catalog Number
- GM11010710
- Company Name
- VARIAN MEDICAL SYSTEMS, INC.
- Labeler DUNS
- 009120817
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-02
- Public Version
- 1
- Public Version Date
- 2021-02-10
- Public Version Status
- New
- Public Device Record Key
- 98d9e014-0391-4cf1-a6dd-8c07098dfa97
Device Description
For Titanium Fletcher-style Applicator Set Defined Geometry
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
- 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 |
|---|---|---|---|---|
| JAQ | System, applicator, radionuclide, remote-controlled | Radiology | 892.5700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38407 | Vaginal brachytherapy system applicator, remote-afterloading | A remote afterloading brachytherapy applicator specifically designed for use in vaginal or transvaginal radiation therapy treatments. It is designed for temporary implantation within the body and serves as a guide for computer-controlled placement and removal of single or multiple radioactive sources in the vaginal area. This GMDN code includes a variety of applicators, e.g., hollow needles or tubes and catheters, and their associated components. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816389025578 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K952913 | 000 |