FDA.reportPublic FDA data

Prometheus Omni Splint Rolled

Primary DI
05060483570099
Brand
Prometheus Omni Splint Rolled
Company
SAFEGUARD MEDICAL TECHNOLOGIES LIMITED
Model
PDF105
Catalog number
PML105
Device description
The Prometheus Omni Splint™ is intended to be used to aid support and immobilize a patient’s limb(s).
Published
2023-05-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
NOCSplint, Extremity, Non-Inflatable, External, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NOCSplint, Extremity, Non-Inflatable, External, Non-SterileGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060483570099PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060483570099050604835700995060483570099

GMDN Terms#

Term, Definition table
TermDefinition
First aid limb splint, mouldable, single-useA portable device intended to be used for emergency immobilization of an injured body extremity (arm or leg). It takes the form of a semi-rigid, padded, metallic sheet, or a wire frame, or a thermoplastic material designed to be manually moulded/curved externally around the limb to create a rigid splint. It is typically intended to be used 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
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
05060483570051Prometheus Traction Splint PDF101PDF1012023-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00810003753779KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
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00810003753816KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
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