FDA UDI
In Commercial Distribution
🇺🇸 United States
Canal-Pro
DI: 07290114351102
·
Model: .
·
FORUM ENGINEERING TECHNOLOGIES (96) LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Canal-Pro
- Primary DI
- 07290114351102
- Version / Model
- .
- Company Name
- FORUM ENGINEERING TECHNOLOGIES (96) LTD.
- Labeler DUNS
- 532219235
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-24
- Public Version
- 1
- Public Version Date
- 2024-01-01
- Public Version Status
- New
- Public Device Record Key
- 17e23f27-e5ed-49d3-8a9f-fb3eea646bab
Device Description
Canal-Pro Apex Locator
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
- 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 |
|---|---|---|---|---|
| LQY | Locator, Root Apex | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16355 | Endodontic apex locator | A dental instrument, using electricity, designed to locate the top of the root canal during endodontic procedures. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290114351102 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K111474 | 000 |