FDA UDI
In Commercial Distribution
🇺🇸 United States
Multi-Purpose Workstation™ Stepper
DI: 00841436118552
·
Model: 610-1397
·
CIVCO MEDICAL INSTRUMENTS CO., INC.
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Multi-Purpose Workstation™ Stepper
- Primary DI
- 00841436118552
- Version / Model
- 610-1397
- Catalog Number
- 610-1397
- Company Name
- CIVCO MEDICAL INSTRUMENTS CO., INC.
- Labeler DUNS
- 134614411
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-06-21
- Public Version
- 2
- Public Version Date
- 2021-09-06
- Public Version Status
- Update
- Public Device Record Key
- c96fcc3e-c4ab-4b78-8087-747f192d21ca
Device Description
For use with sonoScape BCL10-5 transducers
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ITX | Transducer, ultrasonic, diagnostic | Radiology | 892.1570 | 2 |
| IWJ | System, applicator, radionuclide, manual | Radiology | 892.5650 | 1 |
| JAQ | System, applicator, radionuclide, remote-controlled | Radiology | 892.5700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38426 | Prostate brachytherapy system applicator, manual | A manual brachytherapy applicator specifically designed to be used in radiation therapy treatments of the prostate. It is an individual or modular device designed to facilitate manual placement, e.g., puncture, endoscopically guided or diagnostic imaging system guided placement, and/or removal of single or multiple radioactive sources at a treatment site within the prostate. The device may be a fixed design or designed to accommodate individual patient source placement configurations and includes prostate 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 |
|---|---|---|---|---|---|---|
| Direct Marking | 20841436114060 | GS1 | ||||
| Primary | 00841436118552 | GS1 |
Customer Contacts
- Phone
- +1(319)248-6502
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K131161 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 24.3 | Centimeter | |
| Width | 12.2 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 52 – 85 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Away from Sunlight