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Visian Toric ICL (Implantable Collamer Lens for Myopia)
FDA UDIClass III (US FDA UDI)
Identity
- Trade Name
- Visian Toric ICL (Implantable Collamer Lens for Myopia) FDA UDI
- Generic Name
- Umbilical cord clamp/cutter FDA UDI
- Device Name
- Diopter: -14.0; Cylinder 3.5; Overall Diameter (Length): 12.1 FDA UDI
- Model / Reference
- TMICL 12.1 (-14.0/3.5) FDA UDI
- Description
- Diopter: -14.0; Cylinder 3.5; Overall Diameter (Length): 12.1 FDA UDI
Identifiers
- Catalog Number
- TMICL12.1 FDA UDI
- Primary DI / UDI-DI
- 00841542105286 FDA UDI
- PMA Number
- P030016 FDA UDI
- FDA Product Code
- QCB FDA UDI
- GMDN Term
- Umbilical cord clamp/cutter FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 886.3600 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Umbilical cord clamp/cutter
Visian Toric ICL (Implantable Collamer Lens for Myopia) by Staar Surgical Co. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Umbilical cord clamp/cutter.
- Centurion — Centurion Medical Products · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- umbili-CUTTER — Divergent Medical Technologies LLc · Class I
- Medichoice — OWENS & MINOR DISTRIBUTION, INC. · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- Centurion — Centurion Medical Products · Class I
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class I
Cleared under the same submission
P030016 also covers:
- EVO/EVO+VISIAN Implantable Collamer Lens — Staar Surgical Co.
- EVO/EVO+VISIAN Implantable Collamer Lens — Staar Surgical Co.
- EVO/EVO+VISIAN Implantable Collamer Lens — Staar Surgical Co.
- EVO/EVO+VISIAN Implantable Collamer Lens — Staar Surgical Co.
- EVO/EVO+VISIAN Implantable Collamer Lens — Staar Surgical Co.
- EVO/EVO+VISIAN Implantable Collamer Lens — Staar Surgical Co.
- EVO/EVO+VISIAN Implantable Collamer Lens — Staar Surgical Co.
- EVO/EVO+VISIAN Implantable Collamer Lens — Staar Surgical Co.
- EVO/EVO+VISIAN Implantable Collamer Lens — Staar Surgical Co.
- EVO/EVO+VISIAN Implantable Collamer Lens — Staar Surgical Co.
- EVO/EVO+VISIAN Implantable Collamer Lens — Staar Surgical Co.
- EVO/EVO+VISIAN Implantable Collamer Lens — Staar Surgical Co.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Staar Surgical Co.
Sources (1)
- FDA UDI 73837630-a500-47d8-b4c9-e4113a3622ba 36 fields · synced Jun 8, 2026