Prometheus Pelvic Splint PRO400

GUDID 05060483570044

The PPS is a length of black neoprene which is bonded between two polyester layers. The top layer is made from knitted 100% Polyester, which is colored either yellow for the standard PPS, or dark green for the tactical version of the PPS. The bottom layer is also 100% polyester but is colored black for both the standard and the tactical PPS and has a velour finish so is glossy in appearance. The PPS also features two identical 100% nylon belts (blue for the PPS, or black for the tactical version of the PPS), each with a square tab at one end and a triangular anchor at the other. The tab and anchor both feature 100% nylon hook material on the inner surface so allow adherence to the knitted polyester layer on the neoprene. The two identical 100% nylon belts are thread through a 100% nylon tri-glide buckle (black). The PPS is intended for the emergency management of suspected pelvic fracture(s).

SAFEGUARD MEDICAL TECHNOLOGIES LIMITED

Pelvic fracture binder, single-use
Primary Device ID05060483570044
NIH Device Record Key20f04e0c-d09f-49ae-a9bf-1e474e72c134
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrometheus Pelvic Splint
Version Model NumberPRO400
Catalog NumberPRO400
Company DUNS219545612
Company NameSAFEGUARD MEDICAL TECHNOLOGIES LIMITED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS105060483570044 [Primary]

FDA Product Code

HSQBelt, Pelvic, Traction

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-04
Device Publish Date2024-10-27

Devices Manufactured by SAFEGUARD MEDICAL TECHNOLOGIES LIMITED

05060483570044 - Prometheus Pelvic Splint2024-11-04The PPS is a length of black neoprene which is bonded between two polyester layers. The top layer is made from knitted 100% Polyester, which is colored either yellow for the standard PPS, or dark green for the tactical version of the PPS. The bottom layer is also 100% polyester but is colored black for both the standard and the tactical PPS and has a velour finish so is glossy in appearance. The PPS also features two identical 100% nylon belts (blue for the PPS, or black for the tactical version of the PPS), each with a square tab at one end and a triangular anchor at the other. The tab and anchor both feature 100% nylon hook material on the inner surface so allow adherence to the knitted polyester layer on the neoprene. The two identical 100% nylon belts are thread through a 100% nylon tri-glide buckle (black). The PPS is intended for the emergency management of suspected pelvic fracture(s).
05060483570044 - Prometheus Pelvic Splint2024-11-04 The PPS is a length of black neoprene which is bonded between two polyester layers. The top layer is made from knitted 100% Poly
05060483570181 - Prometheus Pelvic Splint (Tactical)2024-11-04 The PPS is a length of black neoprene which is bonded between two polyester layers. The top layer is made from knitted 100% Poly
15060483570041 - Prometheus Pelvic Splint - Case of 40pcs2024-11-04 A case of 40 PPS. The PPS is a length of black neoprene which is bonded between two polyester layers. The top layer is made fro
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05060483571669 - TMT (Tactical Mechanical Tourniquet) - US2024-10-10 The single use Tactical Mechanical Tourniquet (TMT™) is a hemorrhage control device specifically designed for massive hemorrha
05060483571867 - TMT (Tactical Mechanical Tourniquet) 2024-10-10 The single use Tactical Mechanical Tourniquet (TMT™) is a hemorrhage control device specifically designed for massive hemorrha
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05060483571515 - SWAT-T Tourniquet2024-09-11 SWAT-T Stretch-Wrap and Tuck Tourniquet - Orange A Proven Multi-function Life Saving First Aid Device

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