FDA UDI
In Commercial Distribution
🇺🇸 United States
3D Dental
DI: 00817169023968
·
Model: CI-DF100030
·
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 3D Dental
- Primary DI
- 00817169023968
- Version / Model
- CI-DF100030
- Catalog Number
- CI-DF100030
- Company Name
- 3D DENTAL DESIGNS AND DEVELOPMENT, LLC
- Labeler DUNS
- 080194935
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-29
- Public Version
- 1
- Public Version Date
- 2023-01-06
- Public Version Status
- New
- Public Device Record Key
- 61c6b991-a8fb-4af0-b935-9ad4bdd45d5b
Device Description
ULTRASONIC INSERTS DF-1000 30K TRIPLE BEND
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
- No
- 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 |
|---|---|---|---|---|
| ELC | Scaler, Ultrasonic | Dental | 872.4850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 49908 | Borna disease virus neutralizing antibody IVD, kit, fluorescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of neutralizing antibodies to Borna disease virus in a clinical specimen, using Borna disease virus antigens of known specificity and a fluorescent immunoassay method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817169023968 | GS1 |