Aquaplast RT™ Variable Perf™ RT-1892YSD

GUDID 10841962117354

Aquaplast RT VP Hd+Shldr Portrait S-Frame, 3.2mm

Qfix

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• Primary Device ID: 10841962117354
• NIH Device Record Key: 0873f152-ef03-4859-9205-1a3e5c6c7675
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aquaplast RT™ Variable Perf™
• Version Model Number: RT-1892YSD
• Catalog Number: RT-1892YSD
• 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	10841962117354 [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™ Variable Perf™]

• 10841962117378: Aquaplast RT VP Hd+Shldr Portrait S-Frame, 3.2mm
• 10841962117354: Aquaplast RT VP Hd+Shldr Portrait S-Frame, 3.2mm
• 10841962117347: Aquaplast RT VP Hd+Shldr CURVE S-Frame, 3.2mm
• 10841962117323: Aquaplast RT VP Hd+Shldr CURVE S-Frame, 3.2mm
• 10841962116890: Aquaplast RT VP Hd Only Portrait S-Frame,Std.3.2mm
• 10841962116876: Aquaplast RT VP Hd Only Portrait S-Frame,Std.3.2mm
• 10841962116838: Aquaplast RT Variable Perf, Head Only CURVE S-Frame, 3.2 mm, Standard
• 10841962116814: Aquaplast RT Variable Perf, Head Only CURVE S-Frame, 3.2 mm, Standard
• 10841962102756: Aquaplast RT VP Hd+Shldr Portrait S-Frame, 3.2mm
• 10841962102749: Aquaplast RT VP Hd+Shldr Portrait S-Frame, 3.2mm
• 10841962102725: Aquaplast RT VP Hd+Shldr CURVE S-Frame, 3.2mm
• 10841962102718: Aquaplast RT VP Hd+Shldr CURVE S-Frame, 3.2mm
• 10841962102664: Aquaplast RT VP Hd Only Portrait S-Frame,Std.3.2mm
• 10841962102657: Aquaplast RT VP Hd Only Portrait S-Frame,Std.3.2mm
• 10841962102213: Aquaplast RT Variable Perf, Head Only CURVE S-Frame, 3.2 mm, Standard
• 10841962102206: Aquaplast RT Variable Perf, Head Only CURVE S-Frame, 3.2 mm, Standard