FDA UDI
In Commercial Distribution
🇺🇸 United States
NORDENT MANUFACTURING INC
DI: 00840018657403
·
Model: RCACD3
·
NORDENT MANUFACTURING INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NORDENT MANUFACTURING INC
- Primary DI
- 00840018657403
- Version / Model
- RCACD3
- Company Name
- NORDENT MANUFACTURING INC
- Labeler DUNS
- 053187985
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-11-16
- Public Version
- 1
- Public Version Date
- 2020-11-24
- Public Version Status
- New
- Public Device Record Key
- 9291839c-f74a-4667-921f-08943bd0d2c9
Device Description
CARVER, DE, LARGE CLEOID DISCOID #3 (3-6)
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
- 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
- ["Dry Heat Sterilization", "Moist Heat or Steam Sterilization"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EKH | Carver, Dental Amalgam, Operative | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35793 | Dental restoration carver, amalgam, reusable | A hand-held manual dental instrument intended to be used for producing and perfecting anatomical forms in dental amalgam restorations, typically by cutting, scraping, paring, and smoothing finishes and modelling patterns intraorally. It will typically be a double-ended instrument with working ends of various shapes and designs, and a central handle. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840018657403 | GS1 |