FDA UDI
In Commercial Distribution
🇺🇸 United States
Nordent Manufacturing
DI: 00840018661370
·
Model: U15
·
NORDENT MANUFACTURING INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Nordent Manufacturing
- Primary DI
- 00840018661370
- Version / Model
- U15
- Catalog Number
- N/A
- Company Name
- NORDENT MANUFACTURING INC
- Labeler DUNS
- 053187985
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-23
- Public Version
- 1
- Public Version Date
- 2025-10-31
- Public Version Status
- New
- Public Device Record Key
- b48720fe-cc40-49f8-9d81-9151d43f9524
Device Description
Scaler, DE, Xdura, Anterior Sickle Towner U15-Towner U15, DuraLite ROUND Handle
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| ELA | Instrument, Hand, Calculus Removal | 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 | 00840018661370 | GS1 |
Customer Contacts
- Phone
- 8474374780
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 6.5 | Inch |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 60 – 75 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- 65 – 350 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 40 – 60 Percent (%) Relative Humidity