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Sterile Vascular Silicone Ties
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref VL2218Ref VL2215
Identity
- Trade Name
- Vascular Silicone Ties FDA UDI
- Generic Name
- Surgical vessel loop FDA UDI
- Device Name
- Sterile Vascular Silicone Ties EUDAMEDVST Maxi Red, sterile, 0.12” x 32” / 0.3 cm x 81 cm FDA UDIVST Extra Maxi White, sterile, 0.20” x 22” / 0.5 cm x 56 cm FDA UDI
- Model / Reference
- VL2218 EUDAMEDFDA UDIVL2215 EUDAMEDFDA UDI
- Description
- VST Maxi Red, sterile, 0.12” x 32” / 0.3 cm x 81 cm FDA UDIVST Extra Maxi White, sterile, 0.20” x 22” / 0.5 cm x 56 cm FDA UDI
Identifiers
- Catalog Number
- VL2215 FDA UDIVL2218 FDA UDI
- Primary DI / UDI-DI
- 00690521023284 EUDAMEDFDA UDI00690521023291 EUDAMEDFDA UDI
- Basic UDI-DI
- 6905210VSTST100F8 EUDAMED
- FDA Product Code
- HCF FDA UDI
- EMDN Code
- C0699 CARDIOVASCULAR SURGERY INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Surgical vessel loop FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Malta 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
No
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
Sterile Vascular Silicone Ties by Batrik Medical Manufacturing Inc. — 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 | 6905210VSTST100F8 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Batrik Medical Manufacturing Inc.
- EUDAMED SRN
- CA-MF-000007738
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (4)
- EUDAMED 423b8a9a-563c-43f5-ad6a-2d98e7672adc 61 fields · synced Jul 21, 2026
- EUDAMED b0d5c98d-0465-40d3-ba69-a227f4fe25c6 61 fields · synced May 19, 2026
- FDA UDI 64b7e94c-9e89-4505-9ae0-576f0c028fdf 36 fields · synced May 29, 2026
- FDA UDI a42011b1-33e5-456c-97bf-66b3b7003bfc 36 fields · synced May 30, 2026