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Ranfac Suture Grasper
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref RSG-14Model Ranfac Suture Grasper
by Ranfac Corp.
Identity
- Trade Name
- Ranfac Suture Grasper EUDAMEDRSG-14 FDA UDI
- Generic Name
- Suturing unit, single-use FDA UDI
- Device Name
- RSG-14 EUDAMEDRANFAC SUTURE GRASPER, CE MARKED P/N 76103-01M FDA UDI
- Model / Reference
- Ranfac Suture Grasper EUDAMEDRSG-14 EUDAMEDFDA UDI
- Description
- RANFAC SUTURE GRASPER, CE MARKED P/N 76103-01M FDA UDI
Identifiers
- Catalog Number
- RSG-14 FDA UDI
- Primary DI / UDI-DI
- 00857878007804 EUDAMEDFDA UDI
- Basic UDI-DI
- 08586900068300201GA EUDAMED
- FDA Product Code
- HCF FDA UDI
- EMDN Code
- H900399 SUTURE SUPPORT OR REINFORCEMENT SUPPORT DEVICES - OTHER EUDAMED
- GMDN Term
- Suturing unit, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Denmark 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
- Needle Gauge — 14 Gauge FDA UDILength — 15 Centimeter FDA UDI
Ranfac Suture Grasper by Ranfac Corp. — 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 | 08586900068300201GA | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Ranfac Corp.
- EUDAMED SRN
- US-MF-000008871
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED dea155fa-f0fe-4fc6-aefd-979e86f74ec8 61 fields · synced Jun 18, 2026
- FDA UDI c4070631-b7d7-4b49-9002-c213a9ea4192 37 fields · synced May 29, 2026