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Prometheus Pelvic Splint (Tactical)

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref PRO410

by Safeguard Medical Technologies Limited

Identity

Trade Name
Prometheus Pelvic Splint (Tactical) FDA UDI
Generic Name
Pelvic fracture binder, single-use FDA UDI
Device Name
Prometheus Pelvic Splint EUDAMED
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 coloured 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 coloured 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). FDA UDI
Model / Reference
PRO410 EUDAMEDFDA UDI
Description
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 coloured 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 coloured 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). FDA UDI

Identifiers

Catalog Number
PRO410 FDA UDI
Primary DI / UDI-DI
05060483570181 EUDAMEDFDA UDI
Basic UDI-DI
5060483574009A EUDAMED
FDA Product Code
HSQ FDA UDI
EMDN Code
M030599 IMMOBILISATION SYSTEMS AND DEVICES - OTHER EUDAMED
GMDN Term
Pelvic fracture binder, single-use FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
888.5890 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Pelvic fracture binder, single-use

Prometheus Pelvic Splint (Tactical) by Safeguard Medical Technologies Limited — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED

Similar devices

Also classified as Pelvic fracture binder, single-use.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Safeguard Medical Technologies Limited

Sources (2)

  • FDA UDI 0c8f30b6-aac6-4f79-996c-27434e908fd6 34 fields · synced Jul 10, 2026
  • EUDAMED ce39c094-debe-4e32-8b5b-83b987a16d8d 61 fields · synced Jul 10, 2026