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
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M68981139010LEO Patrol Kit0181-1392026-08-25
M68981301030MARCH IFAK Refill0381-3012026-08-25
M6898130330010MARCH IFAK RESUPPLY Cs of 300181-303-302026-08-25
M68981605020K9 Trauma Kit0281-6052026-08-25
M68987155030TX Bleeding Control Kit - Advanced0387-1552026-08-25
M68987232010Stop the Bleed Kit (NJSP)0187-2322026-08-25
M689SDREDC1OTC010SDR-EDC1OTC01SDR-EDC1OTC2026-08-25
M689SDRTBBOTC020SDR Tactical Battle Belt IFAK-OTC02SDR-TBBOTC2026-08-25
M689HHSCK01EA020Simplified Cricothyrotomy Kit02HHSCK01-EA2022-08-10
M68985201020Mojo Vehicle Rescue Bag - Basic0285-2012026-01-30
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

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