FDA UDI
In Commercial Distribution
🇺🇸 United States
Morelli
DI: 07895742008864
·
Model: 75.01.015
·
Dental Morelli Ltda
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Morelli
- Primary DI
- 07895742008864
- Version / Model
- 75.01.015
- Catalog Number
- 75.01.015
- Company Name
- Dental Morelli Ltda
- Labeler DUNS
- 907156371
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-11-09
- Public Version
- 2
- Public Version Date
- 2022-01-24
- Public Version Status
- Update
- Public Device Record Key
- 8640780b-658d-4bc2-a920-4c5a4ed6fcb8
Device Description
Orthodontic positioner and extractor
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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Dry Heat Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ECP | INSTRUMENT, LIGATURE TUCKING, ORTHODONTIC | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62072 | Orthodontic elastomeric appliance pusher | A hand-held device intended to be used by laypersons to remove/apply orthodontic elastomeric appliances (e.g., inter-arch bands, inter-bracket chains) from/to orthodontic brackets. It is typically a thin plastic device with a hook on one end and a pusher on the other, intended to be used by a patient in the home (e.g., before and after eating or sleep). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07895742008864 | GS1 |
Customer Contacts
- Phone
- +551532388226
- [email protected]