FDA.report

CS 8100SC 3D Access

Primary DI
60889975500232
Brand
CS 8100SC 3D Access
Company
CARESTREAM HEALTH, INC.
Model
CS 8100SC 3D Access
Catalog number
5500236
Device description
CS 8100SC 3D ACCESS
Published
2017-02-03
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
60889975500232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
6088997550023260889975500232

GMDN Terms

TermDefinition
Cone beam computed tomography system, head/neckA stationary assembly of mains electricity (AC-powered) devices intended to produce two- or three-dimensional (3-D) diagnostic digital x-ray images of the head/neck using cone beam computed tomography (CBCT). It consists of an x-ray source assembly, high-voltage generator, x-ray detector, processor, reconstruction software, and patient support device (e.g., seat, stabilizing bite block); the patient is typically scanned in an upright position by a rotating arm. It is typically intended for (but not limited to) dental and ear/nose/throat (ENT) applications.

Storage And Handling

TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity0
Storage Environment Temperature-10 Degrees Celsius60 Degrees Celsius

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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