Identity
- Trade Name
- LeadLoc Depth Stop FDA UDI
- Generic Name
- Neurosurgical micro targeting drive FDA UDI
- Device Name
- Leadloc Depth Stop for Medtronic DBS Leads, non-sterile, 10x FDA UDI
- Model / Reference
- 66-AC-DCM-00530 FDA UDI
- Description
- Leadloc Depth Stop for Medtronic DBS Leads, non-sterile, 10x FDA UDI
Identifiers
- Catalog Number
- 66-AC-DCM FDA UDI
- Primary DI / UDI-DI
- 10873263005306 FDA UDI
- 510(k) Number
- K011992 FDA UDI
- FDA Product Code
- HAW FDA UDI
- GMDN Term
- Neurosurgical micro targeting drive 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
No
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Neurosurgical micro targeting drive
LeadLoc Depth Stop by Fhc, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Neurosurgical micro targeting drive.
- microTargeting™ Drive DBS Adapter — FHC, INC. · Class II
- microTargeting™ Array Electrode Carrier and Clamp — FHC, INC. · Class II
- MacroStim Interface (MSI) — FHC, INC. · Class II
- microTargeting™ Directional Lead Holder — FHC, INC. · Class II
- STar™ Drive Frame Adapter — FHC, INC. · Class II
- microTargeting™ Matrix Guide Bushings — FHC, INC. · Class II
- STar™ Drive Frame Adapter — FHC, INC. · Class II
- microTargeting™ Controller — FHC, INC. · Class II
Cleared under the same submission
K011992 also covers:
- Electrode Depth Stop Adapter — FHC, INC.
- Frame Adapter for Leibinger RM™ — FHC, INC.
- LeadLoc Depth Stop — FHC, INC.
- MacroStim Interface (MSI) — FHC, INC.
- microTargeting™ Array Clamp — FHC, INC.
- microTargeting™ Array Electrode Carrier Set — FHC, INC.
- microTargeting™ Cleaning Brushes — FHC, INC.
- microTargeting™ Controller — FHC, INC.
- microTargeting™ Controller — FHC, INC.
- microTargeting™ Controller Handheld Remote Control — FHC, INC.
- microTargeting™ Controller Power Assist System — FHC, INC.
- microTargeting™ Controller with Encoder — FHC, INC.
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
- Fhc, Inc.
Sources (1)
- FDA UDI e8c60628-6db4-49ea-90dc-67ebacffec4d 37 fields · synced May 30, 2026