FDA UDI
In Commercial Distribution
🇺🇸 United States
Maquira
DI: 07898938244237
·
Model: Box with 40 sterilized Surgical Aspirator
·
Maquira Industria de Produtos Odontologicos S/A
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Maquira
- Primary DI
- 07898938244237
- Version / Model
- Box with 40 sterilized Surgical Aspirator
- Catalog Number
- 80322400030
- Company Name
- Maquira Industria de Produtos Odontologicos S/A
- Labeler DUNS
- 679266866
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-07
- Public Version
- 1
- Public Version Date
- 2024-08-15
- Public Version Status
- New
- Public Device Record Key
- 676baacb-d68a-459c-b050-87f1baaec9cf
Device Description
The Surgical Aspirator offers greater safety in procedures, decreasing the risk of contamination of both the professional and his patients. It helps the aspiration of blood and fluids at the time of dental surgeries, periodontics, implants and minor medical surgeries.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EBR | Unit, Suction Operatory | Dental | 872.6640 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37434 | Dental suction system cannula, single-use | A semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, and water during a dental procedure. It is typically made of disposable plastic materials. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07898938244237 | GS1 |