FDA UDI
In Commercial Distribution
🇺🇸 United States
PDT, Inc.
DI: 00813677025173
·
Model: R960 2024 Advent Calendar
·
PDT, INC.
Product Codes
3
GMDN Terms
3
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- PDT, Inc.
- Primary DI
- 00813677025173
- Version / Model
- R960 2024 Advent Calendar
- Catalog Number
- R960
- Company Name
- PDT, INC.
- Labeler DUNS
- 125850144
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-06
- Public Version
- 1
- Public Version Date
- 2024-11-14
- Public Version Status
- New
- Public Device Record Key
- 3f011a1e-9fab-4d6e-bf63-eef40db0f962
Device Description
R960 2024 Advent Calendar Contains: R061 Barnhart 5-6 R093 NEB 128-L5 Mini R138BC Montana Jack® (Breast Cancer Pink) R217 12 OAD Hawkeye R907 A. Battrell™ Quadrant Gracey Duo Pack T060 PingRing™--Sharpness Tester
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- 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, Dry Heat Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EMN | Scaler, Periodontic | Dental | 872.4565 | 1 |
| EIX | Probe, Periodontic | Dental | 872.4565 | 1 |
| EMS | Curette, Periodontic | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35320 | Manual dental scaler, reusable | A hand-held dental instrument designed for removing calculus and other accretions from the surface and between the teeth during dental cleaning and periodontal (gum) therapy. It is typically designed as a one-piece instrument with a pointed, distal end of various shapes and sizes. Also known as a periodontic scaler, it can be a single-ended or double-ended instrument with a handle at the proximal end or positioned centrally. It is usually made of high-grade stainless steel. This is a reusable device. | No | Active |
| 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 |
| 41660 | Periodontal curette | A hand-held dental instrument with a sharp, hollow-ground blade, usually rounded and semicircular in cross-section, used with a pulling action to remove calculus of periodontal pockets and smooth root surfaces; it is not a gingival retraction cord packing tool. It is typically a double-ended instrument with a handle positioned centrally and is 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 | 00813677025173 | GS1 |