FDA.reportPublic FDA data

Prometheus Traction Splint

Primary DI
05060483570051
Brand
Prometheus Traction Splint
Company
SAFEGUARD MEDICAL TECHNOLOGIES LIMITED
Model
PDF101
Catalog number
PDF101
Device description
The Prometheus Traction Splint is designed to be used on those patients with a suspected limb fracture.
Published
2023-05-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
HSPSplint, Traction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSPSplint, TractionOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060483570051PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060483570051050604835700515060483570051

GMDN Terms#

Term, Definition table
TermDefinition
First aid limb splint, non-mouldable, single-useA portable device intended to be used for emergency immobilization of an injured body extremity (arm or leg). It consists of an unpadded, non-mouldable rigid portion which is applied externally to the limb and held in place with straps/ropes, and may be capable or applying traction; it is made of a variety of materials, and may be used in the home or by emergency medical services (EMS). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
219545612
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060483570365Russell Chest Seal (US Version)PDF0680PDF06802023-05-04
05060483570044Prometheus Pelvic SplintPRO400PRO4002024-10-27
05060483570181Prometheus Pelvic Splint (Tactical)PRO410PRO4102024-10-27
15060483570041Prometheus Pelvic Splint - Case of 40pcsPRO400PRO4002024-10-27
05060483571638TMT (Tactical Mechanical Tourniquet) PDF186PDF1862024-10-02
05060483571669TMT (Tactical Mechanical Tourniquet) - USPDF185PDF1852024-10-02
05060483571867TMT (Tactical Mechanical Tourniquet) PDF187PDF1872024-10-02
05060483571508SWAT-T TourniquetPDF165PDF1652024-09-03
05060483571515SWAT-T TourniquetPDF166PDF1662024-09-03
05060483570099Prometheus Omni Splint Rolled PDF105PML1052023-05-04
05060483570105Prometheus Omni Splint Flat PML115PML1152023-05-04
05060483570112Russell PneumoFix (US) PDF112PDF1122023-05-04
05060483570150Prometheus Steady Head PDF104PDF1042023-05-04
05060483570389Prometheus FullStop Tourniquet - BlackPDF180PDF1802023-05-04
05060483570396Prometheus FullStop Tourniquet - Hi VisibilityPDF181PDF1812023-05-04
05060483570402Russel Pneumofix-8 (US) PDF119PDF1192023-05-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975675781490PrepEM WildEMSRUN GROUPHSP2025-11-07
06975675788864Rhino RescueEMSRUN GROUPHSP2025-11-06
06975675788871Rhino RescueEMSRUN GROUPHSP2025-11-06
06975675788888Rhino RescueEMSRUN GROUPHSP2025-11-06
06975675788857Rhino RescueEMSRUN GROUPHSP2025-10-30
06975675788185Rhino RescueEMSRUN GROUPHSP2025-10-29
06975675788192Rhino RescueEMSRUN GROUPHSP2025-10-29
06975675788208Rhino RescueEMSRUN GROUPHSP2025-10-29
06974567745909RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2024-05-13
16974567745906RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2024-05-13
06974567746937RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-06-28
16974567746934RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-06-28
16952534421022SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.HSP2023-04-06
16952534421039SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.HSP2023-04-06
16952534421046SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.HSP2023-04-06
16952534421053SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.HSP2023-04-06
16952534421060SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.HSP2023-04-06
16952534421114SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.HSP2023-04-06
16952534421121SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.HSP2023-04-06
16952534421138SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.HSP2023-04-06
16952534421145SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.HSP2023-04-06
16952534421152SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.HSP2023-04-06
16952534421169SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.HSP2023-04-06
36974567747812RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-03-21
36974567747829RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-03-21
46974567747819RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-03-21
06974567747811RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-03-21
06974567747828RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-03-21
06974567748092RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-03-03
16974567748099RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-03-03