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Compact Cassette - Instrument Cassette - Teal - 1 Count
EUDAMEDFDA UDIClass I (EU MDR)
Ref 50Z915J
Identity
- Trade Name
- Compact Cassette - Instrument Cassette - Teal - 1 Count EUDAMEDCompact Cassette Teal EUDAMEDCompact Cassette FDA UDI
- Generic Name
- Instrument transport trolley system FDA UDI
- Device Name
- Dental Cleaning, Sterilization, Disinfection Accessories EUDAMEDCompact Cassette Teal EUDAMEDTeal, Holds 8 instruments, Open top, rounded holes and corners allow for superior water flow compared to normal cassettes, Covers are attached to the cassette and open and fold back easily FDA UDI
- Model / Reference
- 50Z915J EUDAMEDFDA UDI
- Description
- Teal, Holds 8 instruments, Open top, rounded holes and corners allow for superior water flow compared to normal cassettes, Covers are attached to the cassette and open and fold back easily FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840161309679 EUDAMEDFDA UDI
- Basic UDI-DI
- 0840161300083F EUDAMEDB-00840161309679 EUDAMED
- FDA Product Code
- FSM FDA UDI
- EMDN Code
- S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
- GMDN Term
- Instrument transport trolley system FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 18.01 Centimeter FDA UDIWidth — 9.84 Centimeter FDA UDIHeight — 1.59 Millimeter FDA UDI
Category: Instrument tray, reusable
Compact Cassette - Instrument Cassette - Teal - 1 Count by Zirc Dental Products, Inc. — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Instrument tray, reusable.
- MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
- Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
- Instrument Case — Katena Products, Inc. · Class I
- Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
- MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
- 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
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0840161300083F | Class I | Active |
| EUDAMED | European Union | CE/MDD | 0840161300083F | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Zirc Dental Products Inc.
- EUDAMED SRN
- US-MF-000021065
- Authorised Representative
- Medicom GmbH DE-AR-000005612
Sources (3)
- EUDAMED ec4e5127-8588-42a1-94bb-506ec63f4080 61 fields · synced Jul 29, 2026
- EUDAMED d10f5ca6-021a-4fb9-a575-875665ee0df9 61 fields · synced May 17, 2026
- FDA UDI 48f697ed-7b54-432f-ac30-b2061ff5a99f 34 fields · synced May 29, 2026