Prometheus Omni Splint Flat
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Prometheus Omni Splint Flat FDA UDIPrometheus Omni Splint Rolled FDA UDI
- Generic Name
- First aid limb splint, mouldable, single-use FDA UDI
- Device Name
- PROMETHEUS OMNI SPLINT EUDAMEDThe Prometheus Omni Splint™ is intended to be used to aid support and immobilize a patient’s limb(s). FDA UDI
- Model / Reference
- PML115 EUDAMEDFDA UDIPML105 EUDAMEDPDF105 FDA UDI
- Description
- The Prometheus Omni Splint™ is intended to be used to aid support and immobilize a patient’s limb(s). FDA UDI
Identifiers
- Catalog Number
- PML115 FDA UDIPML105 FDA UDI
- Primary DI / UDI-DI
- 05060483570105 EUDAMEDFDA UDI05060483570099 EUDAMEDFDA UDI
- Basic UDI-DI
- 50604835710595 EUDAMED
- FDA Product Code
- NOC FDA UDI
- EMDN Code
- M03050299 BANDAGES AND SPLINTS - OTHER EUDAMED
- GMDN Term
- First aid limb splint, mouldable, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.3910 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
Yes
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: First aid limb splint, mouldable, single-use
Prometheus Omni Splint Flat by Safeguard Medical Technologies Limited — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as First aid limb splint, mouldable, single-use.
- Redi Splint — FARETEC, INC. · Class I
- Lightning X Products, Inc — Wuxi Emsrun Technology Co., Ltd. · Class I
- MedSource Air Splint Set — MEDSOURCE INTERNATIONAL LLC · Class I
- EMSRUN — Wuxi Emsrun Technology Co., Ltd. · Class I
- Redicare — REDICARE LLC · Class I
- Tealmed — Ningbo Tealmed Emergency Products Co., Ltd. · Class I
- Redi Splint — FARETEC, INC. · Class I
- Redi Splint — FARETEC, INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Safeguard Medical Technologies Limited
Sources (4)
- FDA UDI 8213b5fb-3efa-4854-9e0e-b84e2c322089 34 fields · synced Jul 11, 2026
- FDA UDI 2ee6af35-5a30-4848-b5e5-7f11f2b7e92d 34 fields · synced May 30, 2026
- EUDAMED 2ba28f4c-5e07-49a0-949c-0771a62d1353 61 fields · synced Jul 10, 2026
- EUDAMED acfef406-3ab0-4923-a351-4e548cc5e62e 61 fields · synced Jul 11, 2026