FDA.report

A-dec

Primary DI
10194665000219
Brand
A-dec
Company
A-DEC, INC.
Model
561A
Catalog number
561
Device description
A-dec 561 Support System
Published
2022-11-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EBRUnit, Suction Operatory

Product Code Classifications

CodeDeviceSpecialtyClass
EBRUnit, Suction OperatoryDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10194665000219PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1019466500021910194665000219

GMDN Terms

TermDefinition
Dental cuspidorA device shaped as a round bowl (a vessel), into which the patient will spit out the contents of their mouth during and after dental procedures. This vessel is usually a component of the dental delivery system and will typically have a water supply to allow the filling of a drinking vessel with warmed water for the patient to rinse out their mouth and provide the flushing of the cuspidor to wash away the waste (e.g., blood, tooth and material debris).

Sterilization Methods

Method

Regulatory Flags

DUNS number
009617473
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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