FDA.reportPublic FDA data

PRO PELVIC SPLINT

Primary DI
M68955110020
Brand
PRO PELVIC SPLINT
Company
Safeguard US Operating, LLC
Model
02
Catalog number
55-110
Device description
PRO PELVIC SPLINT1 ea - 6 mm Neoprene Band, 1 ea - Black Velcro Straps with BuckleIntended for the emergency management of suspected pelvic fracture(s).
Published
2025-02-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSQBelt, Pelvic, Traction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSQBelt, Pelvic, TractionOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M68955110020PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Pelvic fracture binder, reusableA belt-like support designed to be wrapped tightly around the pelvis (around the greater trochanters) of a patient suspected of a pelvic fracture to support the pelvis during transportation. Sometimes referred to as a pelvic belt or sling, it is typically intended to be used in an emergency setting. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-428-6074fulfillment@combatmedicalsystems.com

Regulatory Flags#

DUNS number
118492643
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M68980100150INTRAVENOUS INFUSION STARTER SET1580-1002026-05-04
M6898010020040INTRAVENOUS INFUSION STARTER SET Case of 200480-100-202026-05-04
M68980801D160Fresh Whole Blood Donor Transfusion Set1680-801-D2026-05-04
M68980801R120Fresh Whole Blood Recipient Set1280-801-R2026-05-04
M6898250403050MEDIC ENHANCEMENT SET0582-504-032026-06-03
M689801101006080-110-10 Saline Lock Kit Case of 100680-110-102026-05-29
M68980110150SALINE LOCK KIT1580-1102026-05-29
M6898143003020Maritime Boat Box - Advanced0281-430-032026-05-28
M6898444601190Mojo Multi Mission - Advanced1984-446-012026-05-27
M689HHCTUINK01050Chest Tube Insertion Kit05HHCTUINK012026-05-27
M689HHCTUINK0105050Chest Tube Insertion Kit Cast of 505HHCTUINK01-052026-05-27
M689801101005080-110-10 Saline Lock Kit Case of 100580-110-102025-04-16
M68980110140SALINE LOCK KIT1480-1102025-01-11
M6898143003010Maritime Boat Box - Advanced0181-430-032025-07-11
M689HHCTUINK01040Chest Tube Insertion Kit04HHCTUINK012025-12-19
M689HHCTUINK0105040Chest Tube Insertion Kit Cast of 504HHCTUINK01-052025-12-19
M6898444601180Mojo Multi Mission - Advanced1884-446-012025-04-10
M68988143020Micro Trauma Kit - Intermediate0288-1432019-10-29
M6898130301130MARCH IFAK RESUPPLY1381-303-012026-05-05
M6898130301120MARCH IFAK RESUPPLY1281-303-012025-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060483570044Prometheus Pelvic SplintSAFEGUARD MEDICAL TECHNOLOGIES LIMITEDHSQ2024-10-27
05060483570181Prometheus Pelvic Splint (Tactical)SAFEGUARD MEDICAL TECHNOLOGIES LIMITEDHSQ2024-10-27
15060483570041Prometheus Pelvic Splint - Case of 40pcsSAFEGUARD MEDICAL TECHNOLOGIES LIMITEDHSQ2024-10-27
M68955110010PRO PELVIC SPLINTSafeguard US Operating, LLCHSQ2018-05-25