Aquaplast RT™ with Integrated Shim™ RT-A892SD

GUDID 10841962118061

Aquaplast RT Hd & Shldr Portrait S-Frame, 3.2mm , Std Perf w/ Integrated Shim

Qfix

Patient positioning thermoplastic mould material

• Primary Device ID: 10841962118061
• NIH Device Record Key: cae867e4-a873-4057-b418-cbfe14f753b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aquaplast RT™ with Integrated Shim™
• Version Model Number: RT-A892SD
• Catalog Number: RT-A892SD
• 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	10841962118061 [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: 2021-12-28
• Device Publish Date: 2021-12-20

On-Brand Devices [Aquaplast RT™ with Integrated Shim™]

• 10841962118085: Aquaplast RT Hd & Shldr Portrait S-Frame, 3.2mm , Std Perf w/ Integrated Shim
• 10841962118061: Aquaplast RT Hd & Shldr Portrait S-Frame, 3.2mm , Std Perf w/ Integrated Shim