FDA.reportPublic FDA data

PRO PELVIC SPLINT

Primary DI
M68955110010
Brand
PRO PELVIC SPLINT
Company
Safeguard US Operating, LLC
Model
01
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
2018-05-25
Public version status
Update
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
M68955110010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Pelvic 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. It is typically intended to be used in an emergency setting to stabilize pelvic fractures. 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
M6898723101030Bleeding Control Kit0387-231-012026-07-30
M689HHTWBC020TACWrap Multi-Purpose Burn Cravat02HHTWBC2026-07-28
M689HHTWBC25010TACWrap Multi-Purpose Burn Cravat Case of 2501HHTWBC-252026-07-28
M6898810501060Patrol Officer IFAK Basic0688-105-012026-07-27
M6898810502060Patrol Officer IFAK Intermediate0688-105-022026-07-27
M6898810503070Patrol Officer IFAK Advanced0788-105-032026-07-27
M6898723101020Bleeding Control Kit0287-231-012026-07-22
M68920510060Sentinel Chest Trauma Kit0620-5102022-11-28
M68920510050Sentinel Chest Trauma Kit0520-5102022-08-18
M68920510030Sentinel Chest Trauma Kit0320-5102018-09-13
M6898332401060Mojo Combat Lifesaver Bag - Basic0683-324-012019-08-06
M68985205020Mojo Vehicle Rescue Bag - Advanced0285-2052026-07-22
M68985301040Mojo Vehicle Medical Bag - Basic0485-3012026-07-22
M68985303040Mojo Vehicle Medical Bag - Intermediate0485-3032026-07-22
M6898710003060Individual Trauma Kit - Advanced0687-100-032026-07-22
M6898730002040Medical Trauma Kit Shelter in Place (Intermediate)0487-300-022026-07-22
M6898730003050Medical Trauma Kit Shelter in Place (Advanced)0587-300-032026-07-22
M689HHCTUINK01030Chest Tube Insertion Kit03HHCTUINK012025-06-23
M689HHCTUINK0105030Chest Tube Insertion Kit Cast of 503HHCTUINK01-052025-06-23
M6898810502020Patrol Officer IFAK Intermediate0288-105-022018-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M68955110020PRO PELVIC SPLINTSafeguard US Operating, LLCHSQ2025-02-19
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