FDA UDI
In Commercial Distribution
🇺🇸 United States
BrachyGel Vaginal Hydrogel Packing System
DI: 00841439114582
·
Model: RT-5300
·
MEDTEC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- BrachyGel Vaginal Hydrogel Packing System
- Primary DI
- 00841439114582
- Version / Model
- RT-5300
- Catalog Number
- RT-5300
- Company Name
- MEDTEC, INC.
- Labeler DUNS
- 103977526
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-23
- Public Version
- 1
- Public Version Date
- 2024-05-31
- Public Version Status
- New
- Public Device Record Key
- 2ec5fae5-d905-4dbb-9b25-ad1cd628959d
Device Description
BrachyGel Vaginal Hydrogel Packing System (BVHPS)
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
- Yes
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QXR | Vaginal Hydrogel Packing System | Radiology | 892.5735 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38406 | Vaginal brachytherapy system applicator, manual | A manual brachytherapy applicator specifically designed to be used in vaginal or transvaginal radiation therapy treatments. It is an individual or modular device designed to facilitate manual placement, e.g., puncture, topical placement, endoscopically guided placement or diagnostic imaging system guided placement, and removal of single or multiple radioactive sources at a treatment site. The device may be a fixed design or designed to accommodate individual patient source placement configurations and includes vaginal applicators such as hollow needles or tubes, catheters, ovoids or tandems, used in manual brachytherapy applications. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10841439114589 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 00841439114582 | GS1 |
Customer Contacts
- Phone
- +17127378688
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN220052 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius