Identity
- Trade Name
- SAM® Pelvic Sling II EUDAMEDSAM Pelvic Sling II FDA UDI
- Generic Name
- Pelvic fracture binder, single-use FDA UDI
- Device Name
- SAM® Pelvic Sling II EUDAMEDSAM PELVIC SLING SMALL FDA UDI
- Model / Reference
- PS300-OB-EN EUDAMEDFDA UDI
- Description
- SAM PELVIC SLING SMALL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00822045428621 EUDAMEDFDA UDI
- Basic UDI-DI
- 0822045SL01U6 EUDAMED
- FDA Product Code
- IPW 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
- 890.3490 FDA UDI
- Market of Registration
- Netherlands 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
SAM® Pelvic Sling II by SAM Medical Products — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0822045SL01U6 | Class I | Active |
| 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
- SAM Medical Products
- EUDAMED SRN
- US-MF-000002589
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 6c2d72db-6b3b-46cf-874c-426efd2b5a88 61 fields · synced Jun 18, 2026
- FDA UDI c5dc1ba8-ccfe-4b3d-ba77-00d7e67d8b60 34 fields · synced May 30, 2026