Identity
- Trade Name
- LogiCal EUDAMEDMedex FDA UDI
- Generic Name
- Invasive-pressure external transducer, single-use FDA UDI
- Device Name
- Logical Reusable Cables EUDAMED
- Model / Reference
- MX962Z22 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 50351688502160 EUDAMEDFDA UDI
- Basic UDI-DI
- 0887709LogicalRCablesGF EUDAMED
- FDA Product Code
- DRS FDA UDI
- EMDN Code
- Z129099 VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - OTHER EUDAMED
- GMDN Term
- Invasive-pressure external transducer, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2850 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Fixture/appliance dental drill bit, reusable
LogiCal by Icu Medical, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fixture/appliance dental drill bit, reusable.
- Hahn — PRISMATIK DENTALCRAFT, INC. · Class I
- Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A. · Class I
- Bone Compaction Drill — OSSTEM IMPLANT Co., Ltd. · Class I
- Prima Plus — Keystone Dental Inc. · Class I
- FTN Tapered Drill — DIO Corporation · Class I
- Prima — Keystone Dental Inc. · Class I
- Twist Drill — OSSTEM IMPLANT Co., Ltd. · Class I
- Stopper Drill — Megagen Implant Co. Ltd · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0887709LogicalRCablesGF | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ICU Medical, Inc.
- EUDAMED SRN
- US-MF-000009764
- Authorised Representative
- ICU Medical BV NL-AR-000002748
Sources (2)
- EUDAMED 89e68aff-4eb4-4925-9806-aa3969e01ead 61 fields · synced Oct 9, 2026
- FDA UDI b7ffd0c8-b6a9-4137-9b46-4953f3bf6008 32 fields · synced May 29, 2026