FDA UDI
In Commercial Distribution
🇺🇸 United States
High Dose Rate Frame, Civco/BW Stepper
DI: 00852656007281
·
Model: 6063
·
Best Nomos
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- High Dose Rate Frame, Civco/BW Stepper
- Primary DI
- 00852656007281
- Version / Model
- 6063
- Company Name
- Best Nomos
- Labeler DUNS
- 146920025
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-31
- Public Version
- 6
- Public Version Date
- 2022-06-17
- Public Version Status
- Update
- Public Device Record Key
- 257d0eb3-6178-4991-b592-d9dd4e96ee57
Device Description
The High Dose Rate Frame, when used in conjunction with a High Dose Rate Sandwich, is used for assisting the physician in placement of the brachytherapy needles for prostate brachytherapy procedures.
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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| IWJ | System, Applicator, Radionuclide, Manual | Radiology | 892.5650 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60734 | Needle guide, reusable | A non-powered device designed to direct a sharp needle (not included) into its proper course when performing a clinical and/or surgical procedure. Dedicated needle guides are available for many different procedures such as plastic guides for urethral injections, stainless steel guides for transrectal prostate biopsy, guides for ultrasound-guided percutaneous punctures and nerve blocks, guides for electromagnetic device tracking systems, and guides for stereotactic breast biopsies. This is a reusable device intended to be sterilized/disinfected prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00852656007281 | GS1 |
Customer Contacts
- Phone
- (412) 312-6700
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K973786 | 000 |