FDA.report

kVue™ Stradivarius™

Primary DI
10841962109441
Brand
kVue™ Stradivarius™
Company
Qfix
Model
RT-4558KV1
Catalog number
RT-4558KV1
Device description
kVue Stradivarius SBRT insert
Published
2016-09-13
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

Contact Domains

Product Codes

CodeName
JAICouch, radiation therapy, powered

Product Code Classifications

CodeDeviceSpecialtyClass
JAICouch, Radiation Therapy, PoweredRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10841962109441PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1084196210944110841962109441

GMDN Terms

TermDefinition
Indexed-immobilization patient positioning systemA assembly of devices used primarily in radiation therapy applications, and consisting of an indexed treatment or imaging table (couch) that contains locking interfaces used to attach various positioning and immobilization devices to numbered or lettered (indexing) points on the table. It is used to ensure both adequate positioning and immobilization of a patient and to help ensure reproducible alignment between a target portion of the patient's anatomy and the radiation beams or fields used in radiation therapy treatments, diagnostic imaging studies. It may accommodate a variety of anatomically targeted patient positioning and immobilization attachments.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(610)268-0585Compliance@qfix.com

Regulatory Flags

DUNS number
808875397
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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