Identity
- Trade Name
- Suture PassOR PRO™ EUDAMEDSuture PassOR Pro FDA UDI
- Generic Name
- Wire/ligature passer, reusable FDA UDI
- Device Name
- Laparoscopic Access Device / Endoscopic Access Device EUDAMED
- Model / Reference
- RSG-18F-XL EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 09349967000632 EUDAMEDFDA UDI
- Basic UDI-DI
- 93499670FASCLSRE32864ZR EUDAMED
- FDA Product Code
- HCF FDA UDI
- EMDN Code
- H0199 SURGICAL SUTURES - OTHER EUDAMED
- GMDN Term
- Wire/ligature passer, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
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
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 32 Millimeter FDA UDI
Suture PassOR PRO™ by The O R Company Pty Ltd — Class IIa — 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 | 93499670FASCLSRE32864ZR | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- The O R Company Pty Ltd
- EUDAMED SRN
- AU-MF-000010179
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED dc92cf76-5fcd-4e92-9abb-db2d087e319b 61 fields · synced Jun 18, 2026
- FDA UDI ea3ae5fc-1890-47df-9dae-fea0312fb1db 33 fields · synced May 22, 2026