FDA UDI
In Commercial Distribution
🇺🇸 United States
EDEGENDO
DI: 06944843619088
·
Model: EDGEFLOW
·
Guilin Woodpecker Medical Instrument Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- EDEGENDO
- Primary DI
- 06944843619088
- Version / Model
- EDGEFLOW
- Company Name
- Guilin Woodpecker Medical Instrument Co., Ltd.
- Labeler DUNS
- 545272577
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-11
- Public Version
- 1
- Public Version Date
- 2025-03-19
- Public Version Status
- New
- Public Device Record Key
- 2911b6bf-f50d-4338-a122-fbf73fe4c7c7
Device Description
Heat up and soften gutta-percha, and fill the gutta-percha into the root canal after preparation.
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
- 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 |
|---|---|---|---|---|
| EKR | Plugger, Root Canal, Endodontic | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44859 | Gutta-percha injector | A hand-held, pistol-shaped, electrically-heated device used to deliver warmed and softened gutta-percha to the dental root canal. Sticks of gutta-percha are inserted into the device and thermally softened before being squeezed out with the ejection trigger through an application tube of varying sizes into the root canal. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06944843619088 | GS1 |