FDA UDI
In Commercial Distribution
🇺🇸 United States
Axio-Base
DI: D161280200
·
Model: 28020
·
Axiodent Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Axio-Base
- Primary DI
- D161280200
- Version / Model
- 28020
- Company Name
- Axiodent Inc.
- Labeler DUNS
- 119330625
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-02
- Public Version
- 1
- Public Version Date
- 2024-10-10
- Public Version Status
- New
- Public Device Record Key
- 1c1cf8d0-3f9d-4938-b315-c05a616b3489
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EEA | Plate, Base, Shellac | Dental | 872.6200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34808 | Dental base plate | A foundation on which an occlusal rim is built or a trial denture set-up. Dental base plates are made of wax, shellac or polymers and formed individually for one patient (custom-made). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D161280200 | HIBCC |