FDA UDI
In Commercial Distribution
🇺🇸 United States
Morelli
DI: 07895742280901
·
Model: 10.23.935
·
Dental Morelli Ltda
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Morelli
- Primary DI
- 07895742280901
- Version / Model
- 10.23.935
- Catalog Number
- 10.23.935
- Company Name
- Dental Morelli Ltda
- Labeler DUNS
- 907156371
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-26
- Public Version
- 2
- Public Version Date
- 2024-05-30
- Public Version Status
- Update
- Public Device Record Key
- d8c00787-ead8-4f89-93c7-0ed0b6757ebb
Device Description
Kit of Brackets 01 case Prescription M.B.T. - SLH .022" - Hook Can./Bicusp.
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 |
|---|---|---|---|---|
| EJF | BRACKET, METAL, ORTHODONTIC | Dental | 872.5410 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58818 | Self-ligating orthodontic bracket | A ceramic device intended to be bonded to a tooth to hold an orthodontic archwire used to apply pressure to the tooth in order to alter the position of the tooth. It has an integral fixation clip, typically made of a polymer with a metal hinge, to retain the archwire (self-ligating) within a metal insert slot. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded. | No | Active |
| 58937 | Orthodontic bracket, ceramic | A ceramic device intended to be bonded to a tooth to hold an orthodontic archwire used to apply pressure to the tooth in order to alter the position of the tooth. It typically has a metal (e.g., stainless steel) insert slot for the archwire, which is held in place with an orthodontic archwire/bracket fixation ring. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07895742280901 | GS1 |
Customer Contacts
- Phone
- +551532388226
- [email protected]