FDA UDI
In Commercial Distribution
🇺🇸 United States
PDT, Inc.
DI: 00813677021144
·
Model: R169 Explorer ODU 11-12 ER
·
PDT, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- PDT, Inc.
- Primary DI
- 00813677021144
- Version / Model
- R169 Explorer ODU 11-12 ER
- Catalog Number
- R169
- Company Name
- PDT, INC.
- Labeler DUNS
- 125850144
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-30
- Public Version
- 4
- Public Version Date
- 2025-07-25
- Public Version Status
- Update
- Public Device Record Key
- 5902c46a-503d-45b0-ae07-412ce4e582b2
Device Description
R169 - The PDT 11-12 Extended Reach Explorer has a tighter radius on the bends, plus an extended terminal shank, that allow for more adaptive, interproximal access for better calculus detection in deeper pockets. ODU stands for Old Dominion University.
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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EKB | Explorer, Operative | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35812 | Dental surgical probe, reusable | A slender, rod-like, hand-held manual dental surgical instrument intended to be used to explore, measure and/or perform therapeutic procedures during various types of dental surgical intervention. The distal end may be needle-like, hooked, or blunt; it is made of flexible or rigid metallic and/or synthetic polymer material and it may have scaled markings for measurements. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00813677021144 | GS1 |
Customer Contacts
- Phone
- 800-240-9895
- [email protected]