FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Classic Stepper
DI: 00841436108768
·
Model: H40342LL
·
CIVCO MEDICAL INSTRUMENTS CO., INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- Classic Stepper
- Primary DI
- 00841436108768
- Version / Model
- H40342LL
- Catalog Number
- H40342LL
- Company Name
- CIVCO MEDICAL INSTRUMENTS CO., INC.
- Labeler DUNS
- 134614411
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2017-08-22
- Public Version
- 8
- Public Version Date
- 2022-08-23
- Public Version Status
- Update
- Public Device Record Key
- d7fb1ffa-a5e8-4873-8b3b-02e7fcdddaa7
- Distribution End Date
- 2022-07-07
Device Description
For use with GE Healthcare ERB 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 |
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 |
|---|---|---|---|---|---|---|
| Primary | 00841436108768 | GS1 | ||||
| Unit of Use | 80841436108764 | GS1 |
Customer Contacts
- Phone
- +1(319)248-6502
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K970514 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 7.1 | Inch | |
| Height | 1.3 | Inch |