FDA UDI
In Commercial Distribution
🇺🇸 United States
UNIVERSITY OF TEXAS SCALER
DI: 00192896082427
·
Model: 1102-SCUT107-108
·
SONTEC INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- UNIVERSITY OF TEXAS SCALER
- Primary DI
- 00192896082427
- Version / Model
- 1102-SCUT107-108
- Catalog Number
- 1102-SCUT107-108
- Company Name
- SONTEC INSTRUMENTS, INC.
- Labeler DUNS
- 040729840
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-21
- Public Version
- 6
- Public Version Date
- 2019-09-17
- Public Version Status
- Update
- Public Device Record Key
- 10bac778-0c19-46ac-82ad-41ed2bb9617e
Device Description
UNIVERSITY OF TEXAS SCALER #107-108 DOUBLE ENDED BLADES
Device Characteristics
- Single Use
- No
- 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
- No
- 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
- ["Dry Heat Sterilization", "Moist Heat or Steam Sterilization"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EMN | SCALER, 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 |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00192896082427 | GS1 |
Customer Contacts
- Phone
- +1(800) 821-7496
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 40 Degree Shank | ||
| Device Size Text, specify | 13 Millimeter Reach | ||
| Device Size Text, specify | 1 Millimeter Blades |