FDA UDI
In Commercial Distribution
🇺🇸 United States
Apex ID
DI: 08809455602089
·
Model: Apex ID Main Body
·
META SYSTEMS CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Apex ID
- Primary DI
- 08809455602089
- Version / Model
- Apex ID Main Body
- Catalog Number
- 972-0085
- Company Name
- META SYSTEMS CO., LTD.
- Labeler DUNS
- 687503532
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-30
- Public Version
- 2
- Public Version Date
- 2025-11-24
- Public Version Status
- Update
- Public Device Record Key
- 8cf74977-9ea6-41ee-a3a3-abef01c45f42
Device Description
Apex ID is an Electronic Apex Locator designed for use in measuring the working length of root canals.
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
- No
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 | 08809455602089 | GS1 |