Positioning Cushion 301201

GUDID 00841439114094

Head support

MEDTEC, INC.

Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest
Primary Device ID00841439114094
NIH Device Record Keya8469446-4f2d-48a8-9d9c-46f0c2f995e3
Commercial Distribution StatusIn Commercial Distribution
Brand NamePositioning Cushion
Version Model Number301201
Catalog Number301201
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
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
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
GS100841439114094 [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 Date2022-11-23
Device Publish Date2022-11-15

On-Brand Devices [Positioning Cushion]

00841439110638Head support
00841439110348Reusable non-sterile (22.9 x 14 x 7.2cm) head support
00841439104941(167.5 x 51 x 5cm) rectangular cushion
00841439104927(223.5 x 51 x 5cm) rectangular cushion
00841439102251Reusable non-sterile (10.2 x 22.9 x 10.2cm) head support
00841439102244Reusable non-sterile (10.2 x 22.9 x 8.9cm) head support
00841439102237Reusable non-sterile (10.2 x 22.9 x 10.2cm) head support
00841439102220Reusable non-sterile (10.2 x 22.9 x 7.6cm) head support
00841439101384Rectangular cushion (30 x 24 x 5 cm)
0084143910137745 degree wedge (28 x 48 x 14cm)
0084143910136045 degree wedge (28 x 20 x 14cm)
00841439101353Reusable non-sterile head support cushion
0084143910134615 degree wedge (24 x 22 x 7cm)
00841439101339Set of six cushions
00841439101247(46 x 46cm)
00841439101230(120 x 46cm)
00841439101223Back support cushion
00841439101216Reusable non-sterile elevated arm support cushion
00841439101209Reusable non-sterile back support cushion
00841439101193Reusable non-sterile elevated arm support cushion
0084143910118610 degree wedge
008414391011795 degree wedge
00841439101155Flat support
00841439101148Prone thorax support
00841439101100Set of three Elevation Block 3 cushions
00841439101094(43 x 43 x 6cm) Elevation Block 3 cushions
00841439101063Reusable non-sterile (43 x 43 x 6cm) elevation block-2 cushion
00841439101032Shoulder support
00841439101025Head Support (3)
00841439101018Head support (24.2 x 13.3 x 9.5cm)
00841439101001Head support (24.1 x 13.3 x 9.3cm)
00841439100998Head support (24.8 x 13.5 x 10cm)
00841439100943Reusable non-sterile (22.9 x 12.7 x 10.2cm) head support
00841439100936Head support
00841439100929Head support
00841439100905Positioning Cushion Adapter Piece
00841439100882Reusable non-sterile (10.2 x 22.9 x 10.2cm) head support
00841439100875Reusable non-sterile (10.2 x 22.9 x 8.9cm) head support
00841439100868Reusable non-sterile (10.2 x 22.9 x 10.2cm) head support
00841439100851Reusable non-sterile (10.2 x 22.9 x 7.6cm) head support
00841439100844Reusable non-sterile head support
00841439101131Reusable non-sterile Prone thorax support
00841439101087Reusable non-sterile (43 x 43 x 6cm) elevation block-2 cushion
00841439100912Reusable non-sterile flat support
00841439100899Reusable Non-Sterile Head Support
00841439114094Head support
00841439114087Head Support (10.2 x 23.1 x 8.1cm)
00841439114070Head Support (10.2 x 23.1 x 9.5cm)
00841439114063Head Support (10.2 x 23.1 x 9.0cm)
00841439114056Head support (10.2 x 23.1 x 10.9cm)

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