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 ID00841439114124
NIH Device Record Key3e884f90-14da-457e-a2eb-ef0a93fd8ed5
Commercial Distribution StatusIn Commercial Distribution
Brand NamePro Wing Board™
Version Model NumberOAP220
Catalog NumberOAP220
Company DUNS103977526
Company NameMEDTEC, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841439114124 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LNHSystem, nuclear magnetic resonance imaging

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-24
Device Publish Date2022-10-14

Devices Manufactured by MEDTEC, INC.

00841439114650 - Pronumbra2025-09-22 Pronumbra Helping Hand, Left
00841439114674 - Pronumbra2025-09-22 Pronumbra Helping Hand, Right
00841439114681 - Pronumbra2025-09-22 Pronumbra 130cm kVue
00841439114698 - Pronumbra2025-09-22 Pronumbra Neck Support, 40mm
00841439114704 - Pronumbra2025-09-22 Pronumbra Neck Support, 50mm
00841439114711 - Pronumbra2025-09-22 Pronumbra Neck Support, 65mm
00841439114728 - Pronumbra2025-09-22 Pronumbra Shoulder Adapter
00841439114841 - ZiFix Traverse2025-09-22 ZiFix Traverse with ONEClamp

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.