FDA.report

CS 9000C 3D

Primary DI
60889975159010
Brand
CS 9000C 3D
Company
CARESTREAM HEALTH, INC.
Model
CS 9000C 3D
Catalog number
5159017
Device description
CS 9000C 3D 110V
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
OASX-ray, tomography, computed, dental

Product Code Classifications

CodeDeviceSpecialtyClass
OASX-Ray, Tomography, Computed, DentalRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
60889975159010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
6088997515901060889975159010

GMDN Terms

TermDefinition
Stationary cephalometric x-ray system, digitalA stationary cephalometric x-ray system designed to generate and control x-ray beams and to record the absorption patterns of x-rays passing through a patient's head (skull). It is used for: 1) radiographic visualization and measurement of the dimensions of the human head, e.g., abnormal structures of the skull; 2) orthodontic assessment of the relationship of the teeth to the jaws and the jaws to the rest of the facial skeleton; 3) assessment airway and other soft tissue structures. The sensor is placed outside the head. The data is either from analogue imaging and digitized afterwards or by digital imaging.

Sterilization Methods

Method

Regulatory Flags

DUNS number
793169512
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
false
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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