FDA UDI
In Commercial Distribution
🇺🇸 United States
Morelli
DI: 07895742296629
·
Model: 99.65.003
·
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
- 07895742296629
- Version / Model
- 99.65.003
- Catalog Number
- 99.65.003
- Company Name
- Dental Morelli Ltda
- Labeler DUNS
- 907156371
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-10
- Public Version
- 1
- Public Version Date
- 2025-09-18
- Public Version Status
- New
- Public Device Record Key
- ef382de8-1440-47b2-a7f7-0fdfd1d06683
Device Description
Expansion Screw Palatal Split - Expansion 9mm
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
- MR Conditional
- 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 |
|---|---|---|---|---|
| DYJ | RETAINER, SCREW EXPANSION, ORTHODONTIC | Dental | 872.5410 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64769 | Orthodontic palate expander/teeth aligner, bonded | An orthodontic device intended to gradually spread the maxillary arch and/or improve teeth alignment. It is typically in the form of either: 1) a segmented body separated by a palate expander screw; or 2) a spring-like mechanism, positioned in the palate cavity with wires extending laterally, ending in bonded teeth-engaging bands. It is intended to remain in the oral cavity for the duration of treatment (fixed), and may be periodically adjusted by an orthodontist to effect skeletal and/or dental changes. This is a single-patient device intended to be used for the duration of treatment (single-use) before being discarded. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07895742296629 | GS1 |
Customer Contacts
- Phone
- +551532388226
- [email protected]