Identity
- Trade Name
- NGM WAVE Base Tray EUDAMEDNGM WAVE FDA UDI
- Generic Name
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- Container system EUDAMEDAll instruments provided by NGMedical are reusable surgical instruments with the purpose of enabling the implantation of an NGMedical implant. The surgical technique of each implant describes the instruments to be used. The instruments may only be used in direct connection with implants from NGMedical and as described in the respective surgical techniques. FDA UDI
- Model / Reference
- CON24 EUDAMEDPLIF Tray 1 FDA UDI
- Description
- All instruments provided by NGMedical are reusable surgical instruments with the purpose of enabling the implantation of an NGMedical implant. The surgical technique of each implant describes the instruments to be used. The instruments may only be used in direct connection with implants from NGMedical and as described in the respective surgical techniques. FDA UDI
Identifiers
- Catalog Number
- CON24 FDA UDI
- Primary DI / UDI-DI
- 04251631411062 EUDAMEDFDA UDI
- Basic UDI-DI
- 42516314TD021I4B EUDAMED
- Direct Marketing DI
- 04251631411062 EUDAMED
- 510(k) Number
- K212050 FDA UDI
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- V0499 CLINICAL USE CONTAINERS (NON-IVD) - OTHER EUDAMED
- GMDN Term
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Germany 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Instrument transport trolley system
NGM WAVE Base Tray by NGMedical GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Instrument transport trolley system.
- FHK UNIVERSAL PANIER COMMUN N°1 — FOURNITURES HOSPITALIERES INDUSTRIE · Class I
- Silicone holder — Thommen Medical AG · Class I
- Buste di sicurezza per il trasporto di farmaci chemioterapici - antiblastici — LABOINDUSTRIA Spa · Class I
- Sterilisationscontainer — REDA Instrumente GmbH · Class I
- Complete Tub Neon Blue — ZIRC DENTAL PRODUCTS, INC. · Class I
- STERILIZATION BOX — S.I.N. - Sistema DE Implante Nacional S.A. · Class II
- Sterilisationscontainer — REDA Instrumente GmbH · Class I
- ARROW II V1 PANIER EMBASE DE GLENE SC — FOURNITURES HOSPITALIERES INDUSTRIE · 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 | 42516314TD021I4B | 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
- NGMedical GmbH
- EUDAMED SRN
- DE-MF-000000204
Sources (3)
- EUDAMED 4898b559-0a2a-4e3a-a1ee-74823127922a 61 fields · synced Jul 15, 2026
- FDA UDI d6e7505e-5ab0-4040-b2fc-4b8a960fd320 35 fields · synced May 30, 2026
- EUDAMED d77b8e35-410d-4460-9497-2713478ec228 61 fields · synced Jul 15, 2026