FDA UDI
Not in Commercial Distribution
🇺🇸 United States
MOOSER SYSTEM Root post MOOSER
DI: J003C055C011508001
·
Model: C055C01150800
·
MAILLEFER INSTRUMENTS HOLDING Sàrl
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MOOSER SYSTEM Root post MOOSER
- Primary DI
- J003C055C011508001
- Version / Model
- C055C01150800
- Catalog Number
- C055C01150800
- Company Name
- MAILLEFER INSTRUMENTS HOLDING Sàrl
- Labeler DUNS
- 480538495
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-30
- Public Version
- 2
- Public Version Date
- 2024-01-25
- Public Version Status
- Update
- Public Device Record Key
- 295643e1-32f2-4aba-84c0-88e59d0c0acb
- Distribution End Date
- 2023-06-30
Device Description
Mooser System
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
- 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
- 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 | J003C055C011508001 | HIBCC |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- N/A