FDA UDI
In Commercial Distribution
🇺🇸 United States
PROMO KIT ICERAM CLASS II CORRECTOR 27MM
DI: 07908611210104
·
Model: 11.90.1103
·
ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- PROMO KIT ICERAM CLASS II CORRECTOR 27MM
- Primary DI
- 07908611210104
- Version / Model
- 11.90.1103
- Company Name
- ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA
- Labeler DUNS
- 898330003
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-16
- Public Version
- 1
- Public Version Date
- 2024-04-24
- Public Version Status
- New
- Public Device Record Key
- a9fa50ff-2bfa-4538-a753-e3426249ed00
Device Description
PROMO KIT ICERAM CLASS II CORRECTOR 27MM (2UN) + MINI TUBO ICERAM (2UN)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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 |
|---|---|---|---|---|
| DYJ | Retainer, Screw Expansion, Orthodontic | Dental | 872.5410 | 1 |
| DZD | Tube, Orthodontic | Dental | 872.5410 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31759 | Orthodontic tube | A device used in orthodontics to attach a wire(s) or headgear to orthodontic bands bonded to the teeth. It is typically welded to an orthodontic band or bonded to a tooth. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded. | No | Active |
| 35310 | Orthodontic retainer | An orthodontic appliance, bonded or removable, intended to be used on a single patient to maintain teeth in corrected positions during the period of functional adaptation following corrective treatment. This appliance, also referred to as a positioner, is also used to maintain the positions of the teeth and jaws gained by orthodontic procedures. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07908611210104 | GS1 |