Identity
- Trade Name
- VIZADISC FDA UDI
- Generic Name
- Imaging lesion localization marker, external, single-use FDA UDI
- Device Name
- HIP Procedure Tracking Kit FDA UDI
- Model / Reference
- 107130 FDA UDI
- Description
- HIP Procedure Tracking Kit FDA UDI
Identifiers
- Catalog Number
- 107130 FDA UDI
- Primary DI / UDI-DI
- 00848486002534 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Imaging lesion localization marker, external, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Imaging lesion localization marker, external, single-use
Vizadisc by MAKO Surgical Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K121064 also covers:
- DYNASTY — MAKO Surgical Corp.
- RESTORIS — MAKO Surgical Corp.
- RESTORIS — MAKO Surgical Corp.
- RESTORIS — MAKO Surgical Corp.
- RESTORIS, PST, RIO — MAKO Surgical Corp.
- RESTORIS, PST, RIO — MAKO Surgical Corp.
- RESTORIS, PST, RIO — MAKO Surgical Corp.
- RESTORIS, RIO — MAKO Surgical Corp.
- RESTORIS, RIO — MAKO Surgical Corp.
- RESTORIS, RIO — MAKO Surgical Corp.
- RESTORIS, TRINITY, RIO — MAKO Surgical Corp.
- RESTORIS, TRINITY, RIO — MAKO Surgical Corp.
K141989 also covers:
- ACCOLADE II — MAKO Surgical Corp.
- ACCOLADE II — MAKO Surgical Corp.
- ACCOLADE II — MAKO Surgical Corp.
- ACCOLADE II — MAKO Surgical Corp.
- ANATO — MAKO Surgical Corp.
- ANATO — MAKO Surgical Corp.
- ANATO — MAKO Surgical Corp.
- MAKO — MAKO Surgical Corp.
- RESTORIS, PST, Mako — MAKO Surgical Corp.
- RESTORIS, PST, RIO — MAKO Surgical Corp.
- RESTORIS, PST, RIO — MAKO Surgical Corp.
- RESTORIS, PST, RIO — MAKO Surgical Corp.
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 II | Pending data |
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Manufacturer
- Manufacturer
- MAKO Surgical Corp.
Sources (1)
- FDA UDI 77cbb0dc-62ec-4f33-b224-787262b6d003 35 fields · synced Jun 9, 2026