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Z5_Tray_Box
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref Z5_Tray_Box
by Z-Systems AG
Identity
- Trade Name
- Z5_Tray_Box FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- Z5_Tray_Box EUDAMEDSurgical Box FDA UDI
- Model / Reference
- Z5_Tray_Box EUDAMEDFDA UDI
- Description
- Surgical Box FDA UDI
Identifiers
- Catalog Number
- Z5_Tray_Box FDA UDI
- Primary DI / UDI-DI
- 07640166761761 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07640166761761 EUDAMED
- 510(k) Number
- K201878 FDA UDI
- FDA Product Code
- KCT FDA UDI
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6850 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
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Moist Heat or Steam Sterilization FDA UDI
Category: Instrument tray, reusable
Z5_Tray_Box by Z-Systems AG — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Instrument tray, reusable.
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- SHEFFIELD RING FIXATOR — Orthofix, Inc. · Class II
- MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
- ASELTECH — Asel Tibbi Aletler A.S. · Class I
Cleared under the same submission
K201878 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Z-Systems AG
Sources (2)
- FDA UDI 0344eee7-6787-4933-bfd7-2097c22b2e32 36 fields · synced Jul 9, 2026
- EUDAMED 2e03a048-a6fa-40ec-843f-978c83aa86ed 61 fields · synced Jul 9, 2026