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microTargeting™ WayPoint™ Inserter Kit
FDA UDIClass II (US FDA UDI)
by Fhc, Inc.
Identity
- Trade Name
- microTargeting™ WayPoint™ Inserter Kit FDA UDI
- Generic Name
- Neurosurgical micro targeting drive FDA UDI
- Device Name
- microTargeting WayPoint Inserter Kit, 120mm for use with 66-WP-MR kit and microTargeting Platform FDA UDI
- Model / Reference
- 66-WP-ID-00333 FDA UDI
- Description
- microTargeting WayPoint Inserter Kit, 120mm for use with 66-WP-MR kit and microTargeting Platform FDA UDI
Identifiers
- Catalog Number
- 66-WP-ID FDA UDI
- Primary DI / UDI-DI
- 00873263003336 FDA UDI
- 510(k) Number
- K092192 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
- Not 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 120 Millimeter FDA UDI
microTargeting™ WayPoint™ Inserter Kit by Fhc, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K092192 also covers:
- MicroTargeting™ RPD Adapter — FHC, INC.
- MicroTargeting™ Sterilization Basket — FHC, INC.
- OsteoMed™ Manual Driver Handle — FHC, INC.
- STar™ Drive Lead Measurement Fixture — FHC, INC.
- WayPoint™ Anchors — FHC, INC.
- WayPoint™ Anchors — FHC, INC.
- WayPoint™ Combination Driver Bit — FHC, INC.
- WayPoint™ Hex Wrench — FHC, INC.
- WayPoint™ Implantation Kit — FHC, INC.
- WayPoint™ Multi-Oblique Platform — FHC, INC.
- WayPoint™ Navigator — FHC, INC.
- WayPoint™ Navigator — 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 7755c69f-91fd-4656-8532-7f0ef797de97 39 fields · synced May 30, 2026