Prometheus Pelvic Splint
Basic Information
- Brand Name
- Prometheus Pelvic Splint
- Primary DI
- 05060483570044
- Version / Model
- PRO400
- Catalog Number
- PRO400
- Company Name
- SAFEGUARD MEDICAL TECHNOLOGIES LIMITED
- Labeler DUNS
- 219545612
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-27
- Public Version
- 1
- Public Version Date
- 2024-11-04
- Public Version Status
- New
- Public Device Record Key
- 20f04e0c-d09f-49ae-a9bf-1e474e72c134
Device 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).
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HSQ | Belt, Pelvic, Traction | Orthopedic | 888.5890 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63496 | Pelvic fracture binder, single-use | A belt-like support designed to be wrapped tightly around the pelvis (around the greater trochanters) of a patient suspected of a pelvic fracture to support the pelvis during transportation. Sometimes referred to as a pelvic belt or sling, it is typically intended to be used in an emergency setting. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060483570044 | GS1 |