Monarch™ Individual Hand Grips OAP160

GUDID 00841439112595

For use with C-Qual™

MEDTEC, INC.

Radiological breast positioner, non-wearable Radiological breast positioner, non-wearable Radiological breast positioner, non-wearable Radiological breast positioner, non-wearable Radiological breast positioner, non-wearable Radiological breast positioner, non-wearable Radiological breast positioner, non-wearable Radiological breast positioner, non-wearable Radiological breast positioner, non-wearable Radiological breast positioner, non-wearable Radiological breast positioner, non-wearable Radiological breast positioner, non-wearable Radiological breast positioner, non-wearable Radiological breast positioner, non-wearable Radiological breast positioner, non-wearable Radiological breast positioner, non-wearable Radiological breast positioner, non-wearable Radiological breast positioner, non-wearable Radiological breast positioner, non-wearable Radiological breast positioner, non-wearable Radiological breast positioner, non-wearable Radiological breast positioner, non-wearable Radiological breast positioner, non-wearable Radiological breast positioner, non-wearable Radiological breast positioner, non-wearable Radiological breast positioner, non-wearable Radiological breast positioner, non-wearable Radiological breast positioner, non-wearable Radiological breast positioner, non-wearable Radiological breast positioner, non-wearable Radiological breast positioner, non-wearable Radiological breast positioner, non-wearable Radiological breast positioner, non-wearable Radiological breast positioner, non-wearable

• Primary Device ID: 00841439112595
• NIH Device Record Key: 2885c59e-c87b-4847-8fbb-54a686f2fd7d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monarch™ Individual Hand Grips
• Version Model Number: OAP160
• Catalog Number: OAP160
• Company DUNS: 103977526
• Company Name: MEDTEC, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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
• 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
• 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	00841439112595 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093738

FDA Product Code

• IYE: Accelerator, linear, medical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-05-31
• Device Publish Date: 2019-01-07

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