FDA UDI
In Commercial Distribution
🇺🇸 United States
GP Cut Gutta Percha Cutter
DI: 00723896005361
·
Model: 1362
·
PRACTICON, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- GP Cut Gutta Percha Cutter
- Primary DI
- 00723896005361
- Version / Model
- 1362
- Catalog Number
- 71-36210
- Company Name
- PRACTICON, INC.
- Labeler DUNS
- 119193803
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-07-19
- Public Version
- 2
- Public Version Date
- 2023-06-13
- Public Version Status
- Update
- Public Device Record Key
- 11eb1e1b-e95d-476f-a843-49685de1761c
Device Description
Cut gutta percha quickly, cleanly, and safely within the pulp chamber with the cordless GP Cut Gutta Percha Cutter. Hold the power button for one second and the tip will reach up to 1,000°C. Release the button, and the tip cools down in less than one second. Bendable, flexible tips come in three sizes: large (2.0mm wide), medium (1.2mm wide), and small (0.5mm wide). The GP Cut system comes complete with one unit, one base, protective cap, and three tips (one of each size). 7.875" long x .75" wide. Powered by two AA batteries
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| EKD | Instrument, Cutting, Operative | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41876 | Endodontic plugger | A hand-held, manually-operated, dental instrument specifically designed to compress filling materials in a root canal, mainly in an axial direction. The working distal end is cylindrical or tapered, circular in cross-section, and has a flat-tipped end. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00723896005361 | GS1 |