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microTargeting™ Sterile Drape Sleeves
FDA UDIClass II (US FDA UDI)
by Fhc, Inc.
Identity
- Trade Name
- microTargeting™ Sterile Drape Sleeves FDA UDI
- Generic Name
- Patient surgical drape, single-use FDA UDI
- Device Name
- microTargeting Sterile Drape Sleeves 20x, for use with STar and MT Drives with motor or encoder option. FDA UDI
- Model / Reference
- FC1004-00141 FDA UDI
- Description
- microTargeting Sterile Drape Sleeves 20x, for use with STar and MT Drives with motor or encoder option. FDA UDI
Identifiers
- Catalog Number
- FC1004 FDA UDI
- Primary DI / UDI-DI
- 10873263001414 FDA UDI
- 510(k) Number
- K011992 FDA UDI
- FDA Product Code
- HAW FDA UDI
- GMDN Term
- Patient surgical drape, 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
Ethylene Oxide FDA UDI
Category: Patient surgical drape, single-use
microTargeting™ Sterile Drape Sleeves by Fhc, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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.
- 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.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fhc, Inc.
Sources (1)
- FDA UDI 53827fcf-7a41-43af-9d52-e489d4c23d4d 36 fields · synced May 30, 2026