Identity
- Trade Name
- EMSRUN FDA UDI
- Generic Name
- Pelvic fracture binder, reusable FDA UDI
- Model / Reference
- PZGD0003 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974567742809 FDA UDI
- FDA Product Code
- ISR FDA UDI
- GMDN Term
- Pelvic fracture binder, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3025 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
No
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
Yes
FDA UDI
Category: Pelvic fracture binder, reusable
Emsrun by Wuxi Emsrun Technology Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pelvic fracture binder, reusable.
- PRO PELVIC SPLINT — SAFEGUARD US OPERATING, LLC · Class I
- ManaMed — MANAMED LLC · Class I
- PRO PELVIC SPLINT — SAFEGUARD US OPERATING, LLC · Class I
- EMSRUN — Wuxi Emsrun Technology Co., Ltd. · Class I
- EMSRUN — Wuxi Emsrun Technology Co., Ltd. · 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 |
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Manufacturer
- Manufacturer
- Wuxi Emsrun Technology Co., Ltd.
Sources (1)
- FDA UDI 729c33f6-6553-4740-af9c-b77f37d92baa 32 fields · synced May 31, 2026