Vac-Lok™ Cushion VLARM02FC

GUDID 00841439112120

Reusable non-sterile nylon bag (75 x 105cm, 28L) with indexing for arms-up positioning

MEDTEC, INC.

Vacuum-mould patient positioning system
Primary Device ID00841439112120
NIH Device Record Key50255652-9a17-46e2-989d-6116a80085f5
Commercial Distribution StatusIn Commercial Distribution
Brand NameVac-Lok™ Cushion
Version Model NumberVLARM02FC
Catalog NumberVLARM02FC
Company DUNS103977526
Company NameMEDTEC, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100841439112120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYEAccelerator, linear, medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-05-31
Device Publish Date2018-05-07

On-Brand Devices [Vac-Lok™ Cushion]

00841439112472"L" shaped nylon bag (80 x 90cm, 28L)
00841439112458T shape nylon bag (108 x 125cm x 42L)
00841439112427Nylon bag (60 x 100.5cm, 15L) with indexing for pelvic positioning
00841439112410Nylon bag (100 x 150cm, 80L)
00841439112403Nylon bag (100 x 100cm, 40L)
00841439112397Nylon bag (25 x 50cm, 2.25L)
00841439112380Nylon bag (50 x 70cm, 15L)
00841439112373Nylon bag (75 x 150cm, 50L)
00841439112366Nylon bag (70 x 100cm, 35L)
00841439112359Nylon bag (70 x 100cm, 40L)
00841439112342Nylon bag (100 x 200cm, 120L)
00841439112335Reusable non-sterile nylon bag (70 x 70cm, 20L)
00841439112328(75 x 120cm, 34L) nylon bag for pelvic positioning
0084143911231175 x 100cm, 28L, nylon bag for pelvic positioning
00841439112304Nylon bag (55 x 88cm, 15L) for wingboard
00841439112298"L" shaped nylon bag (80 x 100cm, 34L)
00841439112281Reusable non-sterile nylon bag (75 x 75cm, 20L) for arms-up positioning
00841439112274Reusable non-sterile nylon bag (75 x 105cm, 28L) for arms-up positioning
00841439112267(80 x 100cm, 28L) hourglass shaped nylon bag for pelvic positioning
00841439112250"T" shape nylon bag (108 x 125cm, 44L)
00841439112243Nylon bag with indexing (100 x 100cm, 40L)
00841439112236Nylon bag with indexing (50 x 70cm, 15L)
00841439112229Nylon bag with indexing (75 x 150cm, 50L)
00841439112205Nylon bag with indexing (70 x 100cm, 35L)
00841439112199Nylon bag with indexing (70 x 100cm, 40L)
00841439112182Nylon bag with indexing (70 x 70cm, 20L)
00841439112175Nylon bag (75 x 100cm, 28L) with indexing for pelvic positioning
00841439112168Nylon bag (75 x 120cm, 34L) with indexing for pelvic positioning
00841439112151"T" shaped nylon bag (87.5 x 140cm, 25L)
00841439112137Reusable non-sterile nylon bag (75 x 75cm, 20L) with indexing for arms-up positioning
00841439112120Reusable non-sterile nylon bag (75 x 105cm, 28L) with indexing for arms-up positioning
00841439112106Type-S™ nylon bag (61 x 65cm, 8L) with indexing
00841439112090Type-S™ nylon bag (140 x 65cm, 27L) with indexing
00841439112083"L" shaped clear urethane bag (80 x 100cm, 34L)
00841439112076"T" shaped clear urethane bag (50 x 70cm, 6L)
00841439112069Reusable non-sterile clear urethane bag (75 x 75cm, 20L) for arms-up positioning
00841439112052Reusable non-sterile clear urethane bag (75 x 105cm, 28L) for arms-up positioning
00841439112045Clear urethane bag (100 x 100cm, 40L)
00841439112038Clear urethane bag (25 x 50cm, 2.25L)
00841439112021Clear urethane bag (50 x 70cm, 15L)
00841439112014Clear urethane bag (75 x 150cm, 50L)
00841439112007Clear urethane bag (70 x 100cm, 35L)
00841439111994Clear urethane bag (70 x 100cm, 40L)
00841439111987Clear urethane bag (70 x 70cm, 20L)
0084143911197075 x 100cm, 28L, clear urethane bag for pelvic positioning
00841439111963(75 x 120cm, 34L) clear urethane bag for pelvic positioning
00841439111956Clear urethane bag (55 x 88cm, 15L) for wingboard
00841439108673Reusable, non-sterile, 55 x 88cm, 15L, clear urethane bag for wingboard safe for use in 1.5T and
00841439108666140 x 65cm, 27L, Type-S™ nylon bag with indexing
0084143910863580 x 100cm, 28L, hourglass shaped nylon bag for pelvic positioning

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.