FDA UDI
In Commercial Distribution
🇺🇸 United States
CT Comp. Henschke GYN Appl, Titanium
DI: 00817330027283
·
Model: GM13003870
·
MICK RADIO NUCLEAR INSTRUMENT, INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CT Comp. Henschke GYN Appl, Titanium
- Primary DI
- 00817330027283
- Version / Model
- GM13003870
- Catalog Number
- GM13003870
- Company Name
- MICK RADIO NUCLEAR INSTRUMENT, INC
- Labeler DUNS
- 073260622
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-14
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- f2e31795-1a40-40d2-9d67-3dc6c30c7420
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 Safe
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| 38408 | Cervical/intrauterine brachytherapy system applicator, manual | A manual brachytherapy applicator specifically designed to be used in cervical and/or intrauterine radiation therapy treatments. It is an individual or modular device designed to facilitate manual placement, e.g., puncture, endoscopically guided placement or diagnostic imaging system guided placement, 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 cervical/intrauterine 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 | 00817330027283 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K040704 | 000 |