Evolve Slant Board OAP200

GUDID 00841439114155

For use with Evolve breastboard solution

MEDTEC, INC.

Radiological breast positioner, non-wearable
Primary Device ID00841439114155
NIH Device Record Key733ab13d-98a0-45ba-b6b4-e553fab5b02e
Commercial Distribution StatusIn Commercial Distribution
Brand NameEvolve Slant Board
Version Model NumberOAP200
Catalog NumberOAP200
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 Numbertrue
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
GS100841439114155 [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.

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00841439114858 - Headrest - TIMO Size A, B, C, D, E, F2024-12-12 (19.8 x 12.2 x 6.4cm) size A; (22.6 x 11.9 x 6.4cm) size B; (23.1 x 11.7 x 7.4cm) size C; (23.4 x 12.4 x 8.9cm) size D; (21.8 x
00841439114865 - Headrest - Timo Size A2024-12-12 (19.8 x 12.2 x 6.4cm)
00841439114872 - Headrest - Timo size B2024-12-12 (22.6 x 11.9 x 6.4cm)
00841439114889 - Headrest - Timo size C2024-12-12 (23.1 x 11.7 x 7.4cm)
00841439114896 - Headrest - Timo size D2024-12-12 (23.4 x 12.4 x 8.9cm)
00841439114902 - Headrest - Timo size E2024-12-12 (21.8 x 12.2 x 10.2cm)
00841439114919 - Headrest - Timo Size F2024-12-12 (23.4 x 12.2 x 9.1cm)

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