FDA UDI
In Commercial Distribution
🇺🇸 United States
PDT, Inc.
DI: 00813677024923
·
Model: R930 Pineyro Arch™ Implant Kit with Cassette
·
PDT, INC.
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PDT, Inc.
- Primary DI
- 00813677024923
- Version / Model
- R930 Pineyro Arch™ Implant Kit with Cassette
- Catalog Number
- R930
- Company Name
- PDT, INC.
- Labeler DUNS
- 125850144
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-26
- Public Version
- 1
- Public Version Date
- 2024-07-04
- Public Version Status
- New
- Public Device Record Key
- 6a5d8acd-b99b-4d5b-b824-cfadec24bb8f
Device Description
Kit Includes: T005A-F A-Series FlipTop™ Cassette - Fixed Rack 5 R630 Pineyro Arch™ Ti 1 R631 Pineyro Arch™ Ti 2 R632 Pineyro Arch™ Ti 3 R633 Pineyro Arch™ Ti 4
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
- 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, Dry Heat Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | 878.4800 | 1 |
| EMN | Scaler, Periodontic | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12143 | Instrument tray, reusable | A container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device. | No | Active |
| 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 |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00813677024923 | GS1 |