FDA UDI
In Commercial Distribution
🇺🇸 United States
Morelli
DI: 07895742009762
·
Model: 75.02.008
·
Dental Morelli Ltda
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Morelli
- Primary DI
- 07895742009762
- Version / Model
- 75.02.008
- Catalog Number
- 75.02.008
- 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
- 2
- Public Version Date
- 2023-02-06
- Public Version Status
- Update
- Public Device Record Key
- cf9fc775-c6b6-41a2-81e2-0e3bf7dfc3e7
Device Description
Tensiometer of 50 to 500gf (cN) - color Green
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 |
|---|---|---|---|---|
| DZN | INSTRUMENTS, DENTAL HAND | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44861 | Orthodontic appliance force gauge | A hand-held dental instrument intended to be used in orthodontics to accurately measure forces (in grams or ounces) applied by the elastics or springs used when setting up orthodontic appliances within the patient's mouth. The device is typically of cylindrical or tubular design (but can be dial-shaped with circular read out) and is made of metal (some partly plastic); it contains a spring-loaded mechanism which indicates the force exerted to pull the appliance elastic or spring to the desired length. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07895742009762 | GS1 |
Customer Contacts
- Phone
- +551532388226
- [email protected]