N / A
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- N / A FDA UDI
- Generic Name
- Electromagnetic surgical navigation device tracking system FDA UDI
- Device Name
- Instrument Clamp EUDAMEDInstrument Clamp Electromagnetic Universal FDA UDI
- Model / Reference
- 08858250000552RX EUDAMED8000-060-021 EUDAMED8000060021 FDA UDI
- Description
- Instrument Clamp Electromagnetic Universal FDA UDI
Identifiers
- Catalog Number
- 8000-060-021 FDA UDI
- Primary DI / UDI-DI
- 07613327512298 EUDAMEDFDA UDI
- Basic UDI-DI
- 08858250000552RX EUDAMED
- Direct Marketing DI
- 07613327512298 EUDAMED
- FDA Product Code
- PGW FDA UDI
- EMDN Code
- Z12011480 SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Electromagnetic surgical navigation device tracking system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Electromagnetic surgical navigation device tracking system
N / A by Stryker Leibinger — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Electromagnetic surgical navigation device tracking system.
- RTM 92 HS — I.A.E. INDUSTRIA APPLICAZIONI ELETTRONICHE S.P.A. · Class IIb
- Nadeln / Needles — REDA Instrumente GmbH · Class I
- Nadeln / Needles — REDA Instrumente GmbH · Class I
- IA091S — ALFAMED SRL · Class IIa
- Nadeln / Needles — REDA Instrumente GmbH · Class I
- Needle Holder — Shandong Chengwu Medical Products Factory · Class I
- XR90 System, LOGIQ, Upgrade Kit — MediView XR · Class II
- Nadeln / Needles — REDA Instrumente GmbH · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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
- Stryker Leibinger
Sources (2)
- FDA UDI 00d70d6d-c26a-44d6-ba55-1b87431ed040 36 fields · synced Jun 19, 2026
- EUDAMED a3017fa9-5fd9-4f4f-a035-9eec52a680dc 61 fields · synced Jun 14, 2026