FDA.reportPublic FDA data

Prometheus FullStop Tourniquet - Black

Primary DI
05060483570389
Brand
Prometheus FullStop Tourniquet - Black
Company
SAFEGUARD MEDICAL TECHNOLOGIES LIMITED
Model
PDF180
Catalog number
PDF180
Device description
The Prometheus FullStop® tourniquet is a lightweight, durable tourniquet that has been shown to successfully occlude arterial blood flow.
Published
2023-05-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
GAXTourniquet, Nonpneumatic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAXTourniquet, NonpneumaticGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060483570389PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060483570389050604835703895060483570389

GMDN Terms#

Term, Definition table
TermDefinition
Limb tourniquet, manual, single-useA strap or tubing intended to be wrapped around a patient's limb (arm or leg) and manually tightened to reduce blood circulation to or from the portion of the limb distal to where the device is applied. It is typically used by emergency medical services (EMS) for emergency blood loss prevention or for routine blood sampling. It typically does not include latex and may be available in a variety of designs (e.g., Velcro or a self-locking buckle, synthetic rubber band). 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
Donation ID number
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
05060483570396Prometheus FullStop Tourniquet - Hi VisibilityPDF181PDF1812023-05-04
05060483570402Russel Pneumofix-8 (US) PDF119PDF1192023-05-04
05060483570051Prometheus Traction Splint PDF101PDF1012023-05-01

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30382903671985BD Vacutainer® Stretch TourniquetBECTON, DICKINSON AND COMPANYGAX2024-03-13
30382903672098BD Vacutainer® Stretch TourniquetBECTON, DICKINSON AND COMPANYGAX2024-03-13
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