Identity
- Trade Name
- ViewSite Brain Access System EUDAMEDVycor Viewsite Brain Access System with Alignment Clip FDA UDI
- Generic Name
- Neurosurgical retraction cannula FDA UDI
- Device Name
- ViewSite Brain Access System (VBAS) EUDAMEDTHE VYCOR VIEWSITE BRAIN ACCESS SYSTEM (VBAS) WITH ALIGNMENT CLIP (AC) is a family of retractor and brain access devices of varying shapes and sizes designed for providing diagnostic and surgical access to various portions of the brain and spine. It has been designed to serve as a self-retaining retractor system for brain tissue. It is comprised of an introducer and a working channel or port that are secured by a spring-loaded latch. There is also an Alignment Clip (AC) included separately in the packaging that may be optionally attached to aid in the centering of third-party instrumentation, specifically navigational and image guided system (“IGS”) pointers or probes (“pointer”). Each VBAS device allows for the gentle retraction of tissue, visualization of the surgical site and for the manipulation of introduced instruments. The range of device sizes (width and length) provides various working channel sizes. FDA UDI
- Model / Reference
- TC120803AC EUDAMEDFDA UDI
- Description
- THE VYCOR VIEWSITE BRAIN ACCESS SYSTEM (VBAS) WITH ALIGNMENT CLIP (AC) is a family of retractor and brain access devices of varying shapes and sizes designed for providing diagnostic and surgical access to various portions of the brain and spine. It has been designed to serve as a self-retaining retractor system for brain tissue. It is comprised of an introducer and a working channel or port that are secured by a spring-loaded latch. There is also an Alignment Clip (AC) included separately in the packaging that may be optionally attached to aid in the centering of third-party instrumentation, specifically navigational and image guided system (“IGS”) pointers or probes (“pointer”). Each VBAS device allows for the gentle retraction of tissue, visualization of the surgical site and for the manipulation of introduced instruments. The range of device sizes (width and length) provides various working channel sizes. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00859261006258 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00859261006258 EUDAMED
- 510(k) Number
- K202694 FDA UDI
- FDA Product Code
- GZT FDA UDI
- EMDN Code
- K01020106 MINIMALLY INVASIVE SURGERY SPREADERS AND RETRACTORS, SINGLE-USE EUDAMED
- GMDN Term
- Neurosurgical retraction cannula FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4800 FDA UDI
- Market of Registration
- Sweden 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
ViewSite Brain Access System by Vycor Medical, Inc. — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00859261006258 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Vycor Medical Inc.
- EUDAMED SRN
- US-MF-000007171
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (2)
- EUDAMED c8c60389-a3ff-4d0d-ab26-ec087cb57fd9 61 fields · synced Jul 11, 2026
- FDA UDI 60ea57ce-b314-480a-bb91-4b603dcfc50e 34 fields · synced May 30, 2026