FDA UDI
In Commercial Distribution
🇺🇸 United States
Morelli
DI: 07895742220136
·
Model: 47.20.009
·
Dental Morelli Ltda
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Morelli
- Primary DI
- 07895742220136
- Version / Model
- 47.20.009
- Catalog Number
- 47.20.009
- Company Name
- Dental Morelli Ltda
- Labeler DUNS
- 907156371
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-30
- Public Version
- 1
- Public Version Date
- 2021-05-10
- Public Version Status
- New
- Public Device Record Key
- 867c1337-351d-4090-a2bc-6784c5046d9e
Device Description
Anatomic Band L/LR 33mm With Tubes 20.10.411 / 412
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 |
|---|---|---|---|---|
| DYO | BAND, MATERIAL, ORTHODONTIC | Dental | 872.5410 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38734 | Orthodontic metal band | A thin metal ring designed to be fitted around the contours of a tooth and cemented into place to support an orthodontic attachment (e.g., bracket, tube), brazed or soldered onto the ring, intended to be secured to the tooth. 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 | 07895742220136 | GS1 |
Customer Contacts
- Phone
- +551532388226
- [email protected]