FDA.report

QS-500

Primary DI
60889976573402
Brand
QS-500
Company
CARESTREAM HEALTH, INC.
Model
QS-500
Catalog number
6573406
Device description
QS-506 RADIOGRAPHIC TUBE STAND 6FT TRCK
Published
2016-09-16
Public version status
Update
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
IYBTube mount, x-ray, diagnostic

Product Code Classifications

CodeDeviceSpecialtyClass
IYBTube Mount, X-Ray, DiagnosticRadiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
60889976573402PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
6088997657340260889976573402

GMDN Terms

TermDefinition
X-ray system tube support, floor standA floor stand is a hardware assembly with its related mechanical, electronic or software controls that form the structure used to mount, support and facilitate positioning of the x-ray tube assembly sub-system of either a diagnostic x-ray system, therapeutic x-ray system, or an x-ray system designed for use as a radiation therapy simulator. Typically mobile, some designs also support and coordinate the movement and positioning of a radiographic cassette or image receptor assembly with respect to the position of the x-ray tube, e.g., a C-arm assembly. It is considered to be a component of a x-ray system.

Sterilization Methods

Method

Regulatory Flags

DUNS number
793169512
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
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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