FDA.report

A-dec

Primary DI
10194665000332
Brand
A-dec
Company
A-DEC, INC.
Model
2671A
Catalog number
2671
Device description
2671 Cascade Cart
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
EIAUnit, Operative Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EIAUnit, Operative DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10194665000332PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1019466500033210194665000332

GMDN Terms

TermDefinition
Dental delivery systemA stationary, mains electricity (AC-powered) device assembly designed to provide dental staff with the necessary utilities/amenities to deliver dental treatment to a patient. The utilities/amenities are typically compressed air, water, suction, electricity, table top or bracket table surfaces, cuspidor, gas, and sometimes the dental light. This is a fixed-position system (i.e., not mobile) which incorporates an instrument unit for dental instrument provision. The patient examination/treatment chair is typically integrated as part of this system.

Sterilization Methods

Method

Regulatory Flags

DUNS number
009617473
Device count
1
DM exempt
false
Premarket exempt
false
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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