Identity
- Trade Name
- microTargeting™ Stylet FDA UDI
- Generic Name
- Scalpel, single-use FDA UDI
- Device Name
- microTargeting DP Stylet, for use with mT Drive and STar Drive FDA UDI
- Model / Reference
- 66-ST-12P-00824 FDA UDI
- Description
- microTargeting DP Stylet, for use with mT Drive and STar Drive FDA UDI
Identifiers
- Catalog Number
- 66-ST-12P FDA UDI
- Primary DI / UDI-DI
- 00873263008249 FDA UDI
- 510(k) Number
- K011775 FDA UDI
- FDA Product Code
- HAW FDA UDI
- GMDN Term
- Scalpel, 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 244.5 Millimeter FDA UDI
Category: Scalpel, single-use
microTargeting™ Stylet by Fhc, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Scalpel, single-use.
- MANI ENT Knife — MANI, INC. · Class I
- Unique Edge — Unique Technologies, Inc. · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- comknife® — Beijing Bohai Kangyuan Medical Devices Co., Ltd. · Class I
- Bard-Parker ® Disposable Scalpels — Aspen Surgical Products, Inc. · Class I
- Sharpoint — Surgical Specialties México, S. de R.L. de C.V. · Class I
- comknife® — Beijing Bohai Kangyuan Medical Devices Co., Ltd. · Class I
- Stylus — Surgical Specialties México, S. de R.L. de C.V. · Class I
Cleared under the same submission
K011775 also covers:
- 33 cm Lead Insertion Tube Set — FHC, INC.
- Microtargeting ™ STar Drive Adapter — FHC, INC.
- STar™ Drive Insertion Tube Extractor — FHC, INC.
- microTargeting Insertion Tube — FHC, INC.
- microTargeting™ Array Electrode Carrier and Clamp — FHC, INC.
- microTargeting™ Electrode and Insertion Tube — FHC, INC.
- microTargeting™ Frame Adapter — FHC, INC.
- microTargeting™ Insertion Tube — FHC, INC.
- microTargeting™ Insertion Tube — FHC, INC.
- microTargeting™ Insertion Tube — FHC, INC.
- microTargeting™ Insertion Tube — FHC, INC.
- microTargeting™ Insertion Tube — 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 ce250a1d-4fd1-4acf-b8af-621844aefc8f 38 fields · synced May 30, 2026