Voss PronePositioner

GUDID 00811304020102

Voss PronePostioner head rest/face pillow used in prone procedures

VM/POSITIONING, INC.

Freestanding patient positioner, single-use
Primary Device ID00811304020102
NIH Device Record Keybb884882-0d6d-4950-9a50-cf6d225e5955
Commercial Distribution StatusIn Commercial Distribution
Brand NameVoss PronePositioner
Version Model NumberP-3901
Company DUNS023574260
Company NameVM/POSITIONING, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100811304020102 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KILPositioner, Socket

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-01-08
Device Publish Date2018-01-31

Devices Manufactured by VM/POSITIONING, INC.

00811304020553 - Voss Laminectomy Harness2020-03-05 Disposable Foam Laminectmy Harness 3" x 5" x 24"
00811304020577 - Voss Convoluted Arm Board2020-03-05 Disposable foam convoluted arm board 2" x 8" x 20"
00811304020102 - Voss PronePositioner2019-01-08Voss PronePostioner head rest/face pillow used in prone procedures
00811304020102 - Voss PronePositioner2019-01-08 Voss PronePostioner head rest/face pillow used in prone procedures
00811304020126 - Voss Supine Positioner 2019-01-08 Disposable foam supine positioner
00811304020522 - Voss 7" Round Support2019-01-08 7" disposable foam round head support
00811304020539 - Voss 9" Round Support2019-01-08 9" disposable foam round head support
00811304020546 - Voss Medium Body Wedge2019-01-08 Disposable foam medium body wedge 8" x 8" x 17"
00811304020560 - Voss Chest Roll 5" x 17"2019-01-08 Disposable foam chest roll 5" x 17"

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