FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Kobold® Fletcher-model Tandem and Ovoid Applicator Set (V)
DI: 00815568020182
·
Model: 701-000
·
KOBOLD, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Kobold® Fletcher-model Tandem and Ovoid Applicator Set (V)
- Primary DI
- 00815568020182
- Version / Model
- 701-000
- Company Name
- KOBOLD, LLC
- Labeler DUNS
- 014292258
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2019-08-19
- Public Version Status
- Update
- Public Device Record Key
- ecff929e-8e00-47fe-8ae9-b68f1fee1315
- Distribution End Date
- 2019-07-26
Device Characteristics
- Single Use
- No
- 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 Unsafe
- 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 |
|---|---|---|---|---|
| 38409 | Cervical/intrauterine brachytherapy system applicator, remote-afterloading | A remote afterloading brachytherapy applicator specifically designed for use in cervical or intrauterine radiation therapy treatments. It is designed for temporary implantation within the body and serve as a guide for computer-controlled placement and removal of single or multiple radioactive sources in the cervical or intrauterine anatomy. This GMDN code includes a wide variety of applicators, e.g., hollow needles, tubes, or catheters, and their associated components. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815568020182 | GS1 |