Aquaplast RT™ RT-1889ESDL

GUDID 10841962115619

Aquaplast RT Head Only CURVE S-Frame, 3.2 mm, Long

Qfix

Patient positioning thermoplastic mould material

• Primary Device ID: 10841962115619
• NIH Device Record Key: 64c4aa6a-35c4-4e19-8a67-3e21c24c902c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aquaplast RT™
• Version Model Number: RT-1889ESDL
• Catalog Number: RT-1889ESDL
• Company DUNS: 808875397
• Company Name: Qfix
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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

Device Dimensions

• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841962115619 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K935067

FDA Product Code

• IYE: Accelerator, linear, medical

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: 2021-12-27
• Device Publish Date: 2021-12-17

On-Brand Devices [Aquaplast RT™]

• 10841962111185: Aquaplast RT Head Only BoS, 2.4mm Standard Perf
• 10841962111161: Aquaplast RT Head Only BoS, 2.4mm Standard Perf
• 10841962110355: Aquaplast Orfit 4-Point, 2.4mm
• 10841962110348: Aquaplast Orfit 3-Point, Std, 2.4mm
• 10841962110331: Aquaplast PR 5-Point, 2.4mm Locks
• 10841962110324: Aquaplast PR 4-Point, 2.4mm Locks
• 10841962110317: Aquaplast PR 3-Point, Std, 2.4mm Locks
• 10841962110300: Aquaplast Orfit 5-Point, 2.4mm
• 10841962110294: Aquaplast Orfit 4-Point, 2.4mm
• 10841962110287: Aquaplast Orfit 3-Point, Std, 2.4mm
• 10841962110102: Aquaplast Orfit 4-Point Pelvis, 3.2mm
• 10841962110096: Aquaplast PR 5-Point, 2.4mm Locks
• 10841962110089: Aquaplast PR 3-Point, Std, 2.4mm Locks
• 10841962110072: Aquaplast PR 2-Point, 2.4mm Locks
• 10841962110065: Aquaplast Orfit 5-Point, 2.4mm
• 10841962112243: Aquaplast RT PR 4-Point, 2.4mm Locks
• 10841962112229: Aquaplast RT PR 4-Point, 2.4mm Locks
• 10841962112212: Aquaplast RT PR 4-Point, 2.4mm
• 10841962112199: Aquaplast RT PR 4-Point, 2.4mm
• 10841962112182: Aquaplast RT PR 3-Point, Std, 2.4mm Locks
• 10841962112168: Aquaplast RT PR 3-Point, Std, 2.4mm Locks
• 10841962112151: Aquaplast RT PR 3-Point, Std, 2.4mm
• 10841962112137: Aquaplast RT PR 3-Point, Std, 2.4mm
• 10841962112120: Aquaplast RT 20cm Chin Strap
• 10841962112106: Aquaplast RT 20cm Chin Strap
• 10841962112090: Aquaplast RT PR 2-Point, 2.4mm
• 10841962112076: Aquaplast RT PR 2-Point, 2.4mm
• 10841962112069: Aquaplast RT Orfit 5-Point, 2.4mm
• 10841962112045: Aquaplast RT Orfit 5-Point, 2.4mm
• 10841962112038: Aquaplast RT Orfit 4-Point, 2.4mm
• 10841962112014: Aquaplast RT Orfit 4-Point, 2.4mm
• 10841962112007: Aquaplast RT Orfit 3-Point, Std, 2.4mm
• 10841962111987: Aquaplast RT Orfit 3-Point, Std, 2.4mm
• 10841962111703: Aquaplast RT Sheet, 18" x 24", 2.4mm
• 10841962111680: Aquaplast RT Sheet, 18" x 24", 2.4mm
• 10841962111529: Aquaplast RT Sheet, 2.4mm, 18" x 24", Solid
• 10841962111505: Aquaplast RT Sheet, 2.4mm, 18" x 24", Solid
• 10841962111499: Aquaplast RT Sheet, 18" x 24", 2.4mm, Solid
• 10841962111475: Aquaplast RT Sheet, 18" x 24", 2.4mm, Solid
• 10841962111468: Aquaplast RT Slim U-Frame, Ext, 1.6mm
• 10841962111444: Aquaplast RT Slim U-Frame, Ext, 1.6mm
• 10841962111437: Aquaplast RT Cosmas Cup, Size E
• 10841962111413: Aquaplast RT Cosmas Cup, Size E
• 10841962111383: Aquaplast RT Cosmas Cup, Size D
• 10841962111369: Aquaplast RT Cosmas Cup, Size D
• 10841962111352: Aquaplast RT Cosmas Cup, Size C
• 10841962111338: Aquaplast RT Cosmas Cup, Size C
• 10841962111321: Aquaplast RT Cosmas Cup, Size B
• 10841962111307: Aquaplast RT Cosmas Cup, Size B
• 10841962113868: Aquaplast RT Sheet, 12" x 18", 2.4mm, Perf