← Back to catalogue
microTargeting™ Electrode Sterilization Tray
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref FC1001Ref 67-00-1
by Fhc, Inc.
Identity
- Trade Name
- microTargeting™ Electrode Sterilization Tray EUDAMEDFDA UDI
- Generic Name
- Surgical instrument/implant rack FDA UDI
- Device Name
- Electrode Sterilization Tray EUDAMEDmicroTargeting Electrode Sterilization Tray FDA UDI
- Model / Reference
- FC1001 EUDAMED67-00-1 EUDAMEDFC1001-00140 FDA UDI67-00-1-00704 FDA UDIFC1001-00837 FDA UDI
- Description
- microTargeting Electrode Sterilization Tray FDA UDI
Identifiers
- Catalog Number
- FC1001 FDA UDI67-00-1 FDA UDI
- Primary DI / UDI-DI
- 00873263007044 EUDAMEDFDA UDI00873263008379 EUDAMEDFDA UDI00873263001400 FDA UDI
- Basic UDI-DI
- 087326300.00-102-1-A.RE EUDAMED
- Direct Marketing DI
- 00873263008379 EUDAMED00873263007044 EUDAMED
- 510(k) Number
- K033173 FDA UDI
- FDA Product Code
- GZL FDA UDI
- EMDN Code
- S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
- GMDN Term
- Surgical instrument/implant rack FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1330 FDA UDI
- Market of Registration
- Romania EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDIIn Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDIFDA UDI
microTargeting™ Electrode Sterilization Tray by Fhc, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Cleared under the same submission
K033173 also covers:
- Insertion Tube — FHC, INC.
- microTargeting™ Array Electrode — FHC, INC.
- microTargeting™ Array Electrode — FHC, INC.
- microTargeting™ Differential Electrode — FHC, INC.
- microTargeting™ Electrode — FHC, INC.
- microTargeting™ Electrode — FHC, INC.
- microTargeting™ Electrode — FHC, INC.
- microTargeting™ Electrode — FHC, INC.
- microTargeting™ Electrode — FHC, INC.
- microTargeting™ Electrode — FHC, INC.
- microTargeting™ Electrode — FHC, INC.
- microTargeting™ Electrode — FHC, INC.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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 (5)
- FDA UDI 20059aef-3738-4344-a817-908c3a3f70ef 37 fields · synced Sep 17, 2026
- FDA UDI f5e0a2bd-c6f4-48a2-bf05-c9e0de914771 36 fields · synced May 30, 2026
- FDA UDI 54f97f6a-917a-43b3-9019-1d5eeef1fd34 36 fields · synced May 30, 2026
- EUDAMED e54e3b7f-a95f-4503-99a6-dafc8a0c3fa0 61 fields · synced Jul 11, 2026
- EUDAMED a8f753ac-152c-4453-8d1a-9754350e20e7 61 fields · synced Sep 17, 2026