Pro Wing Board™ OAP220

GUDID 00841439114124

Wing Board™ with gel head cup and (2) Pro Handles

MEDTEC, INC.

Radiological breast positioner, non-wearable

• Primary Device ID: 00841439114124
• NIH Device Record Key: 3e884f90-14da-457e-a2eb-ef0a93fd8ed5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pro Wing Board™
• Version Model Number: OAP220
• Catalog Number: OAP220
• Company DUNS: 103977526
• Company Name: MEDTEC, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439114124 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211001

FDA Product Code

• LNH: System, nuclear magnetic resonance imaging

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: 2022-10-24
• Device Publish Date: 2022-10-14

Devices Manufactured by MEDTEC, INC.

• 00841439114612 - Wedge: 2024-07-17 5 degree wedge, MR
• 00841439114629 - Spacer: 2024-07-17 20mm spacer, MR
• 00841439114636 - Spacer: 2024-07-17 30mm spacer, MR
• 00841439114643 - Wedge and Spacer Set: 2024-07-17 2.5 degree wedge, 5 degree wedge, 20mm spacer, and 30mm spacer, MR
• 10841439114589 - BrachyGel Vaginal Hydrogel Packing System: 2024-05-31 BrachyGel Vaginal Hydrogel Packing System (BVHPS)
• 00841439114599 - Pro Posifix® Headrest Adapter: 2024-05-24 Pro Posifix® Headrest Adapter
• 10841439113650 - ProForm™ Thermoplastic: 2024-02-20 IMRT style 18 thermoplastic (3.2mm)
• 10841439113667 - ProForm™ Thermoplastic: 2024-02-20 IMRT FreedomView thermoplastic (3.2mm)