Access 360™

Primary DI
10841962108802
Brand
Access 360™
Company
Qfix
Model
RT-4544KV-12
Catalog number
RT-4544KV-12
Device description
kVue Access 360 G2 Left 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

Contact Domains#

Product Codes#

Code, Name table
CodeName
JAICouch, radiation therapy, powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAICouch, Radiation Therapy, PoweredRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841962108802PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084196210880210841962108802

GMDN Terms#

Term, Definition table
TermDefinition
Radiological breast positioner, non-wearableA device that is specifically designed to ensure adequate positioning and immobilization of the female patient's breast(s) and chest during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures. The device is in the form of a frame, board, cushion, or preformed pad (non-wearable device) and may also be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841962120562FibreplastRT-A182KYSDNRT-A182KYSDN2026-05-26
00841962120456Alta for HexaPODRT-4800-05RT-4800-052026-01-14
00841962120388Lumen AirShuttleXT-5100-80XT-5100-802025-12-02
00841962120395Symphony Locating Bar, PH StyleRT-5100-11PHRT-5100-11PH2025-12-02
00841962120401Portrait Head Only Mask Adapter for Access SupineRT-4546-03RT-4546-032025-12-02
00841962120418Portrait Head & Neck Mask Adapter for Access SupineRT-4546-04RT-4546-042025-12-02
10841962119464Symphony Locating Bar, PH StyleRT-5100-11PHRT-5100-11PH2025-10-23
00841962119856IntegraBiteRT-A001RT-A0012025-11-13
00841962120340Edge Guide SystemRT-5100-55RT-5100-552025-09-11
00841962119467Alpine StirrupsRT-5100-54LRT-5100-54L2025-07-09
00841962119474Alpine StirrupsRT-5100-54RRT-5100-54R2025-07-09
00841962119481Symphony™RT-5100-48RT-5100-482025-07-09
00841962119498AirDrive Trolley™RT-5100-12RT-5100-122025-07-09
00841962119504Access Arm SupportRT-4546AA-01RT-4546AA-012025-07-09
00841962119511Access Wrist SupportRT-4546AW-01RT-4546AW-012025-07-09
00841962119528AirShuttle Locating BarRT-5100-11ERT-5100-11E2025-07-09
00841962119535AirShuttle Locating BarRT-5100-11RT-5100-112025-07-09
00841962119542AirShuttle Transfer HandleRT-5100-10-BRT-5100-10-B2025-07-09
00841962119559InfinityLock™RT-5100-10-ART-5100-10-A2025-07-09
00841962119573AirShuttle Transfer HandleRT-5100-10RT-5100-102025-07-09

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00841962120418Portrait Head & Neck Mask Adapter for Access SupineQfixJAI2025-12-02
00841962119504Access Arm SupportQfixJAI2025-07-09
00841962119511Access Wrist SupportQfixJAI2025-07-09
00841962119610Locating BarQfixJAI2025-07-09
00841962119627FlexLock™QfixJAI2025-07-09
00841962119788Locating BarQfixJAI2025-07-09
00841962119870Opti-HandlesQfixJAI2025-07-09
00841962119887Opti-HandlesQfixJAI2025-07-09
00841962119894Opti-HandlesQfixJAI2025-07-09
00841962119900Opti-HandlesQfixJAI2025-07-09
00841962119917Opti-HandlesQfixJAI2025-07-09
03700383510215ORION SystemBIZLINK ROBOTIC SOLUTIONS FRANCE S.A.S.JAI2025-04-10
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