FDA UDI
In Commercial Distribution
🇺🇸 United States
Park Dental Research Corp
DI: D769DRT150
·
Model: DRT-15
·
PARK DENTAL RESEARCH CORP
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Park Dental Research Corp
- Primary DI
- D769DRT150
- Version / Model
- DRT-15
- Company Name
- PARK DENTAL RESEARCH CORP
- Labeler DUNS
- 011441508
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-11-09
- Public Version
- 3
- Public Version Date
- 2018-11-22
- Public Version Status
- Update
- Public Device Record Key
- 0c91a7d4-8118-4101-8527-b6046b864fc2
Device Description
1.5mm Surgical Drill
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| NDP | Accessories, Implant, Dental, Endosseous | Dental | 872.3980 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47563 | Fluted surgical drill bit, single-use, non-sterile | A non-sterile shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, its shaft is mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device intended to be sterilized prior to use. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D769DRT150 | HIBCC |
Customer Contacts
- Phone
- 1-800-243-7372
- [email protected]