FDA.reportPublic FDA data

Voss PronePositioner

Primary DI
00811304020102
Brand
Voss PronePositioner
Company
VM/POSITIONING, INC.
Model
P-3901
Device description
Voss PronePostioner head rest/face pillow used in prone procedures
Published
2018-01-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KILPositioner, Socket

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KILPositioner, SocketOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K932187000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K932187000PRONE POSITIONERVoss Medical Products1993-06-01KIL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811304020102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811304020102008113040201028113040201020811304020102

GMDN Terms#

Term, Definition table
TermDefinition
Freestanding patient positioner, single-useA preformed patient-contact device (e.g., cushion, pad, bolster, wedge, elevation pillow) designed to be placed freely on a flat surface (e.g., operating table, stretcher) to position and stabilize a patient or body part typically in preparation for and during various medical procedures [e.g., to align the head, neck and thorax to optimise laryngoscopy in anaesthesia]; it is not attached to a parent device. It is made of shock-absorbing materials (e.g., memory foam) to reduce pressure on the bony prominences of a body part (e.g., torso, arm, leg), and some types are inflatable to provide variable support (e.g., to level the spine in a lateral position). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
023574260
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811304020140Voss Cervical Laminectomy HarnessCLH-58K2018-01-31
00811304020553Voss Laminectomy Harness714-LAC2018-06-11
00811304020577Voss Convoluted Arm Board714-CAB2018-06-11
00811304020126Voss Supine Positioner SN-10222018-06-11
00811304020522"Voss 7"" Round Support"714-7RS2018-06-11
00811304020539"Voss 9"" Round Support"714-9RS2018-06-11
00811304020546Voss Medium Body Wedge714-MBW2018-06-11
00811304020560"Voss Chest Roll 5"" x 17"""714-CR2018-06-11
00811304020584Voss Adult Supine Head Rest714-AHR2018-06-11
00811304020591Voss Small Bolster714-SB2018-06-11
00811304020119Voss Cardiac Leg SupportL-39022018-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840277133618Innomed, Inc.INNOMED, INC.KIL2026-04-21
08437019739454WasherCap™ Countersink Positioner 11mmABANZA TECNOMED SL.KIL2026-03-30
06974940306727endophixSuzhou Endophix Co., Ltd.KIL2026-03-03
06974940306758endophixSuzhou Endophix Co., Ltd.KIL2026-03-03
00840277133182Innomed, Inc.INNOMED, INC.KIL2026-02-06
00840277133199Innomed, Inc.INNOMED, INC.KIL2026-02-06
00840277133205Innomed, Inc.INNOMED, INC.KIL2026-02-06
00840277133212Innomed, Inc.INNOMED, INC.KIL2026-02-06
00840277133229Innomed, Inc.INNOMED, INC.KIL2026-02-06
00840277133236Innomed, Inc.INNOMED, INC.KIL2026-02-06
06974940306680endophixSuzhou Endophix Co., Ltd.KIL2025-12-12
06974940306697endophixSuzhou Endophix Co., Ltd.KIL2025-12-12
00840277133021Innomed, Inc.INNOMED, INC.KIL2025-11-10
00840277132888Innomed, Inc.INNOMED, INC.KIL2025-10-14
00840277132765Innomed, Inc.INNOMED, INC.KIL2025-09-12
00840277132772Innomed, Inc.INNOMED, INC.KIL2025-09-12
00840277132789Innomed, Inc.INNOMED, INC.KIL2025-09-12
00840277132796Innomed, Inc.INNOMED, INC.KIL2025-09-12
00840277132802Innomed, Inc.INNOMED, INC.KIL2025-09-12
00840277132833Innomed, Inc.INNOMED, INC.KIL2025-09-12
00840277132734Innomed, Inc.INNOMED, INC.KIL2025-08-27
00840277132659Innomed, Inc.INNOMED, INC.KIL2025-08-11
00840277132666Innomed, Inc.INNOMED, INC.KIL2025-08-11
00840277132628Innomed, Inc.INNOMED, INC.KIL2025-08-04
00840277132611Innomed, Inc.INNOMED, INC.KIL2025-07-09
00840277132406Innomed, Inc.INNOMED, INC.KIL2025-06-25
00840277132390Innomed, Inc.INNOMED, INC.KIL2025-06-17
00840277132239Innomed, Inc.INNOMED, INC.KIL2025-06-04
00840277132246Innomed, Inc.INNOMED, INC.KIL2025-06-04
00840277132253Innomed, Inc.INNOMED, INC.KIL2025-06-04