Adapt-It™ RT-7001

GUDID 10841962117835

Adapt-It Thermoplastic Pellets, 1 lb. bag

Qfix

Patient positioning foam mould kit

• Primary Device ID: 10841962117835
• NIH Device Record Key: 7eff5125-6985-436f-9182-52942d12d1eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Adapt-It™
• Version Model Number: RT-7001
• Catalog Number: RT-7001
• 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

Device Dimensions

• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound
• Weight: 1 Pound

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841962117835 [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 [Adapt-It™]

• 10841962117842: Adapt-It Thermoplastic Pellets, 3 lb. tub
• 10841962117835: Adapt-It Thermoplastic Pellets, 1 lb. bag
• 10841962107348: Adapt-It Thermoplastic Pellets, 3 lb. tub
• 10841962107331: Adapt-It Thermoplastic Pellets, 1 lb. bag