FDA UDI
In Commercial Distribution
🇺🇸 United States
WOODPECKER
DI: 06944843608907
·
Model: PD2L
·
Guilin Woodpecker Medical Instrument Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- WOODPECKER
- Primary DI
- 06944843608907
- Version / Model
- PD2L
- 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
- 2017-10-21
- Public Version
- 4
- Public Version Date
- 2022-10-24
- Public Version Status
- Update
- Public Device Record Key
- ed9fcfb3-bd36-47a2-8921-45f989a5cfc9
Device Description
Ultrasonic dental scaling/debridement system handpiece tip, endodontic
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| ELC | Scaler, Ultrasonic | Dental | 872.4850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46035 | Ultrasonic dental scaling/debridement system handpiece tip, endodontic | An insert intended to be attached to an ultrasonic dental scaling/debridement system handpiece, to transmit ultrasonic energy (e.g., 25 kHz/30 kHz) from a generator to fragment and dislodge the debris within the dental pulp for removal during an endodontic procedure; it is not primarily intended for dental cleaning or periodontal therapy. Also referred to as an ultrasonic endodontic file or rasp, it is available in a variety of forms and sizes, and is typically made of metal. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06944843608907 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K053555 | 000 |