FDA.reportPublic FDA data

Voss Laminectomy Harness

Primary DI
00811304020553
Brand
Voss Laminectomy Harness
Company
VM/POSITIONING, INC.
Model
714-LAC
Device description
"Disposable Foam Laminectmy Harness 3"" x 5"" x 24"""
Published
2018-06-11
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
BTXBoard, Arm (With Cover), Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTXBoard, Arm (With Cover), SterileGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811304020553PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811304020553008113040205538113040205530811304020553

GMDN Terms#

Term, Definition table
TermDefinition
Arm procedure positioner, reusableA preformed device designed to support and stabilize a patient's arm in a desired position during a medical procedure [e.g., orthopaedic surgery, anaesthesia administration, blood donation, intravenous (IV) infusion, physical therapy massage]. Also known as an arm posturing device or armboard, it is typically constructed as an elongated, curved, cushioned surface, and is typically attached or fixed onto a side rail, operation/examination table, blood donor couch, or a chair, and has adjustable height, tilt, rotation, and lock positioning capabilities. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length24Inch

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
023574260
Device count
1
Premarket exempt
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
00811304020577Voss Convoluted Arm Board714-CAB2018-06-11
00811304020102Voss PronePositionerP-39012018-01-31
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
00860014655944MedtronicQuantum Ops, Inc.BTX2025-12-19
10192253021110ArgyleCardinal Health 200, LLCBTX2021-02-15
10192253021134ArgyleCardinal Health 200, LLCBTX2021-02-15
50192253021118ArgyleCardinal Health 200, LLCBTX2021-02-15
50192253021132ArgyleCardinal Health 200, LLCBTX2021-02-15
10192253021127ArgyleCardinal Health 200, LLCBTX2021-02-10
50192253021125ArgyleCardinal Health 200, LLCBTX2021-02-10
10884527006458ArgyleCardinal Health, Inc.BTX2018-06-30
10884527006472ArgyleCardinal Health, Inc.BTX2018-06-30
30884527006452ArgyleCardinal Health, Inc.BTX2018-06-30
30884527006476ArgyleCardinal Health, Inc.BTX2018-06-30
10884527006465ArgyleCardinal Health, Inc.BTX2018-06-27
30884527006469ArgyleCardinal Health, Inc.BTX2018-06-27
00058582006359ADVOCATE ORAL & RECTAL THERMOMETERDIABETIC SUPPLY OF SUNCOAST, INC.BTX2017-02-06