Identity
- Trade Name
- Prometheus Pelvic Splint FDA UDI
- Generic Name
- Pelvic fracture binder, single-use FDA UDI
- Device Name
- 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). FDA UDI
- Model / Reference
- PRO400 FDA 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 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). FDA UDI
Identifiers
- Catalog Number
- PRO400 FDA UDI
- Primary DI / UDI-DI
- 05060483570044 FDA UDI
- FDA Product Code
- HSQ FDA UDI
- GMDN Term
- Pelvic fracture binder, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.5890 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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 by Safeguard Medical Technologies Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pelvic fracture binder, single-use.
- TM "Rehabilitimed" GR-3P XL Comfort — REABILITIMED TOV · Class I
- ARROW — TELEFLEX INCORPORATED · Class I
- TM "Rehabilitimed" GR-3P L Comfort — REABILITIMED TOV · Class I
- Pelvic Binder, Inc. — Pelvic Binder, Inc. · Class I
- ARROW — TELEFLEX INCORPORATED · Class I
- TM "Rehabilitimed" GR-3P S Comfort — REABILITIMED TOV · Class I
- TM "Rehabilitimed" GR-3P XL Comfort — REABILITIMED TOV · Class I
- TM "Rehabilitimed" GR-3P M Comfort — REABILITIMED TOV · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Safeguard Medical Technologies Limited
Sources (1)
- FDA UDI 20f04e0c-d09f-49ae-a9bf-1e474e72c134 34 fields · synced Jun 8, 2026