FDA UDI
In Commercial Distribution
🇺🇸 United States
CERVICAL MATRIX
DI: 07897990342103
·
Model: 0005040000
·
TDV DENTAL LTDA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CERVICAL MATRIX
- Primary DI
- 07897990342103
- Version / Model
- 0005040000
- Catalog Number
- 0005040000
- Company Name
- TDV DENTAL LTDA
- Labeler DUNS
- 900580358
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-28
- Public Version
- 1
- Public Version Date
- 2025-03-10
- Public Version Status
- New
- Public Device Record Key
- 052b7aad-2e7e-4372-8810-baf25ce3dff6
Device Description
Cervical Matrix - 2 Instruments + 10 Matrices (PT/ES/EN/FR)
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| EKF | Instrument, Contouring, Matrix, Operative | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38530 | Dental spatula, reusable | A hand-held manual dental device used to manipulate filling materials in the plastic state. It is typically made of stainless steel with a small, flat, blunt blade (no sharp edges) at one end, or it may be double-ended. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07897990342103 | GS1 |