FDA UDI
In Commercial Distribution
🇺🇸 United States
FIBRAPOST PLUS N°2
DI: 07640159162902
·
Model: 22597
·
Produits dentaires S.A.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FIBRAPOST PLUS N°2
- Primary DI
- 07640159162902
- Version / Model
- 22597
- Company Name
- Produits dentaires S.A.
- Labeler DUNS
- 480420090
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-22
- Public Version
- 1
- Public Version Date
- 2022-06-30
- Public Version Status
- New
- Public Device Record Key
- d2188349-46a3-4236-b525-dc5f7a159236
Device Description
Glass fibre posts - Core build up - Rack of 12 Total Length 19mm Length of tapered part 11mm Diameter of the lower tip 1.06mm Diameter of the cylindrical part 1.50mm
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ELR | Post, Root Canal | Dental | 872.3810 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38609 | Root canal post, preformed | A prefabricated endodontic rod designed for insertion into the root canal of a patient to support and retain a crown prosthesis. It is typically a solid, cylindrical, metal (e.g., stainless steel, gold alloy) piece with a proximal end appropriate to support the crown on top; it is, however, available in a variety of shapes, dimensions, and materials (e.g., ceramics, fibre-reinforced polymers). In addition, it is available in a variety of types (e.g., non-threaded, pre-threaded, or self-tapping; straight or tapered). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07640159162902 | GS1 |
Customer Contacts
- Phone
- +41219212631
- [email protected]