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Suture PassOR PRO™
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref RSG-18F-XLRef RSG-14FRef RSG-14/18F
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 EUDAMEDRSG-14F EUDAMEDFDA UDIRSG-14/18F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09349967004456 EUDAMED09349967000366 EUDAMEDFDA UDI09349967004425 EUDAMED09349967004333 EUDAMED
- 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
- Denmark EUDAMEDFrance EUDAMEDSweden 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 (5)
- EUDAMED a79c905e-fd4f-48ec-a9eb-3b8966971d2d 61 fields · synced Jul 27, 2026
- EUDAMED 56c6e7da-1d84-421c-aba3-d8d3390122e9 61 fields · synced May 17, 2026
- EUDAMED 502240c6-e474-4e7c-b607-81eb84af421e 61 fields · synced May 18, 2026
- EUDAMED 4b122713-7a3a-401a-8827-fe8845622f96 61 fields · synced May 18, 2026
- FDA UDI 6a14d44e-de12-41e5-8b37-ceb84c44b721 33 fields · synced May 30, 2026