FDA UDI
In Commercial Distribution
🇺🇸 United States
Vector R&D, Inc
DI: 00810113691053
·
Model: 10-HE-S
·
Vector R&D, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Vector R&D, Inc
- Primary DI
- 00810113691053
- Version / Model
- 10-HE-S
- Catalog Number
- 10-HE-S
- Company Name
- Vector R&D, Inc.
- Labeler DUNS
- 825399723
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-07
- Public Version
- 1
- Public Version Date
- 2023-02-15
- Public Version Status
- New
- Public Device Record Key
- 09bf16d4-ac35-48e2-81d3-6608d74563ea
Device Description
Piezo Technologies Autoclavable Replacement Handpiece Only - Satelec* Type
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
- MR Unsafe
- Direct Marking Exempt
- Yes
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ELC | Scaler, ultrasonic | Dental | 872.4850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66245 | Dental surgical power tool motorized handpiece/set, electric | An electrically-powered one-piece device or modular device collection designed to accept an endpiece(s) [e.g., drill bit, saw blade] for drilling, cutting, polishing, and/or inserting procedures involving bones and tough tissues during a dental surgical procedure. It includes an electric motor and the appropriate attachments (e.g., angle adaptor, torque multiplier) at its distal end for connection of the endpieces and may include a rechargeable battery or a control unit; the endpieces are not included. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810113691053 | GS1 |
Customer Contacts
- Phone
- +1(253)263-7208
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K040396 | 000 |