Voss PronePositioner

GUDID 00811304020102

Voss PronePostioner head rest/face pillow used in prone procedures

VM/POSITIONING, INC.

Freestanding patient positioner, single-use Freestanding patient positioner, single-use

• Primary Device ID: 00811304020102
• NIH Device Record Key: bb884882-0d6d-4950-9a50-cf6d225e5955
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Voss PronePositioner
• Version Model Number: P-3901
• Company DUNS: 023574260
• Company Name: VM/POSITIONING, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811304020102 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K932187

FDA Product Code

• KIL: Positioner, Socket

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-01-08
• Device Publish Date: 2018-01-31

Devices Manufactured by VM/POSITIONING, INC.

• 00811304020553 - Voss Laminectomy Harness: 2020-03-05 Disposable Foam Laminectmy Harness 3" x 5" x 24"
• 00811304020577 - Voss Convoluted Arm Board: 2020-03-05 Disposable foam convoluted arm board 2" x 8" x 20"
• 00811304020102 - Voss PronePositioner: 2019-01-08Voss PronePostioner head rest/face pillow used in prone procedures
• 00811304020102 - Voss PronePositioner: 2019-01-08 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 Support: 2019-01-08 7" disposable foam round head support
• 00811304020539 - Voss 9" Round Support: 2019-01-08 9" disposable foam round head support
• 00811304020546 - Voss Medium Body Wedge: 2019-01-08 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"