FDA.report

Maquira

Primary DI
07898938244237
Brand
Maquira
Company
Maquira Industria de Produtos Odontologicos S/A
Model
Box with 40 sterilized Surgical Aspirator
Catalog number
80322400030
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.
Published
2024-08-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
EBRUnit, Suction Operatory

Product Code Classifications

CodeDeviceSpecialtyClass
EBRUnit, Suction OperatoryDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07898938244237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07898938244237078989382442377898938244237

GMDN Terms

TermDefinition
Dental suction system cannula, single-useA 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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
679266866
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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