VacQfix™ RT-4517-PB1M

GUDID 10841962119259

VacQfix Cushion, Prone Breast Cushion w/Contralateral Breast Support

Qfix

Vacuum-mould patient positioning system

• Primary Device ID: 10841962119259
• NIH Device Record Key: b07cc959-bb75-442a-9adf-026f9b7c4483
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VacQfix™
• Version Model Number: RT-4517-PB1M
• Catalog Number: RT-4517-PB1M
• Company DUNS: 808875397
• Company Name: Qfix
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com

Device Dimensions

• Width: 112 Centimeter
• Length: 100 Centimeter
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• Length: 100 Centimeter
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• Length: 100 Centimeter
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• Length: 100 Centimeter
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• Length: 100 Centimeter
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• Length: 100 Centimeter
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• Length: 100 Centimeter
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• Length: 100 Centimeter
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• Width: 112 Centimeter
• Length: 100 Centimeter
• Width: 112 Centimeter
• Length: 100 Centimeter
• Width: 112 Centimeter
• Length: 100 Centimeter
• Width: 112 Centimeter
• Length: 100 Centimeter
• Width: 112 Centimeter
• Length: 100 Centimeter
• Width: 112 Centimeter
• Length: 100 Centimeter
• Width: 112 Centimeter
• Length: 100 Centimeter
• Width: 112 Centimeter
• Length: 100 Centimeter
• Width: 112 Centimeter
• Length: 100 Centimeter
• Width: 112 Centimeter
• Length: 100 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841962119259 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060671

FDA Product Code

• JAI: Couch, radiation therapy, powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-11
• Device Publish Date: 2022-02-03

On-Brand Devices [VacQfix™]

• 10841962111079: VacQfix Cushion, 96 X 55cm, 15L Fill
• 10841962111062: VacQfix Cushion, 96 X 55cm, 12L Fill
• 10841962119358: VacQfix Cushion 79cm x 93cm, 20L fill
• 10841962119341: VacQfix Cushion 79cm x 93cm, 20L fill
• 10841962119334: VacQfix Cushion, 65cm x 65cm, T-Shaped, 7L fill
• 10841962119327: VacQfix Cushion, 65cm x 65cm, T-Shaped , 7L fill
• 10841962119310: VacQfix Cushion, 96 X 55cm, 15L Fill
• 10841962119303: VacQfix Cushion, 96 x 55 cm, 15L Fill
• 10841962119297: VacQfix Cushion, 96 X 55cm, 12L Fill
• 10841962119280: VacQfix Cushion, 96 x 55 cm, 12L Fill
• 10841962119273: VacQfix Cushion, Prone Breast Cushion Without Contralateral Breast Support
• 10841962119266: VacQfix Cushion, Prone Breast Cushion Without Contralateral Breast Support
• 10841962119259: VacQfix Cushion, Prone Breast Cushion w/Contralateral Breast Support
• 10841962119242: VacQfix Cushion, Prone Breast Cushion w/Contralateral Breast Support
• 10841962119235: VacQFix Indexer
• 10841962119228: VacQfix Cushion, 150cm x 80cm, 65L fill
• 10841962119211: VacQfix Cushion, 150cm x 80cm, 65L fill
• 10841962119204: VacQfix Cushion, 70cm x 70cm, 20L fill
• 10841962119198: VacQfix Cushion, 70cm x 70cm, 20L fill
• 10841962119181: Vac Q-Fix Cushion 70 x 230 , 65L fill (Economy valve)
• 10841962119174: VacQfix Cushion 70 x 230 , 65L fill
• 10841962119167: VacQfix Cushion 70cm x 150cm 60L
• 10841962119150: VacQfix Cushion, 70cm x 150cm, 60L fill
• 10841962119143: Vac-Q-Fix Cushion, 120xm x 70cm, 40L Fill Gen.II (Economy valve)
• 10841962119136: VacQfix Cushion, 120xm x 70cm, 40L Fill Gen.II
• 10841962119129: VacQfix Cushion, 50cm x 70cm, 15L fill
• 10841962119112: VacQfix Cushion, 50cm x 70cm, 15L fill
• 10841962119105: VacQfix Cushion, 40cm x 80cm, 15L fill
• 10841962119099: VacQfix Cushion, 40cm x 80cm, 15L fill
• 10841962119082: VacQfix Cushion 40cm x 80cm, 15L Fill
• 10841962119075: VacQfix Cushion, 40cm x 79cm, 15L fill
• 10841962119068: Vac-Q-Fix Cushion, 25cm x 35cm, 2.0L fill (Economy valve)
• 10841962119051: VacQfix Cushion, 25cm x 35cm, 2.0L fill
• 10841962119044: Vac-Q-Fix Cushion, 25cm x 35cm, 1.5L fill (Economy valve)
• 10841962119037: VacQfix Cushion, 25cm x 35cm, 1.5L fill
• 10841962119020: VacQfix Cushion, 120/20cm x 230cm,90L fill
• 10841962119013: VacQfix Cushion, 120/80cm x 230cm, 90L fill
• 10841962119006: Vac-Q-Fix Cushion 120cm x 75cm, 35L Fill (Economy valve)
• 10841962118993: VacQfix Cushion 120cm x 75cm, 35L Fill
• 10841962118986: Vac-Q-Fix Cushion, 100cm x 70cm, 43L fill (Economy valve)
• 10841962118979: VacQfix Cushion, 100cm x 70cm, 43L fill
• 10841962118962: VacQfix Cushion, 100cm x 70cm, 40L fill
• 10841962118955: VacQfix Cushion, 100cm x 70cm, 40L fill
• 10841962118948: VacQfix Cushion, 100cm x70cm, 35 liter Fill
• 10841962118931: VacQfix Cushion, 100 cm x 70 cm 35 liter Fill
• 10841962118924: VacQfix Cushion, 100cm x 70cm, 30L fill
• 10841962118917: VacQfix Cushion, 100cm x 70cm, 30L fill
• 10841962118900: VacQfix Cushion, 100cm x 220cm, 120L fill
• 10841962118894: VacQfix Cushion, 100cm x 220cm, 120L fill
• 10841962118887: VacQfix Cushion, 100cm x 150cm, 70L fill