FDA UDI
In Commercial Distribution
🇺🇸 United States
Nordent Manufacturing, Inc.
DI: 00840018663602
·
Model: RENSGR17-18M
·
NORDENT MANUFACTURING INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Nordent Manufacturing, Inc.
- Primary DI
- 00840018663602
- Version / Model
- RENSGR17-18M
- Catalog Number
- Nordent Catalog Hygiene section
- Company Name
- NORDENT MANUFACTURING INC
- Labeler DUNS
- 053187985
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-04
- Public Version
- 2
- Public Version Date
- 2026-01-05
- Public Version Status
- Update
- Public Device Record Key
- 1444fa7a-bf05-40ea-8580-d543d9b0e131
Device Description
Curette, DE, Xdura, Gracey #17-18 Mini Blade, 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
- Yes
- 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 |
|---|---|---|---|---|
| EMS | Curette, Periodontic | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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 | 00840018663602 | 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
- 65 – 75 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 350 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 40 – 60 Percent (%) Relative Humidity