Identity
- Trade Name
- Compact Cassette Red EUDAMEDCompact Cassette - Instrument Cassette - Red - 1 Count EUDAMEDCompact Cassette FDA UDI
- Generic Name
- Instrument transport trolley system FDA UDI
- Device Name
- Compact Cassette Red EUDAMEDDental Cleaning, Sterilization, Disinfection Accessories EUDAMEDRed, Holds 8instruments, 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
- 50Z915M EUDAMEDFDA UDI
- Description
- Red, Holds 8instruments, 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
- 00840161309686 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840161309686 EUDAMED0840161300083F 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 Red by Zirc Dental Products, Inc. — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | B-00840161309686 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-00840161309686 | 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
- Zirc Dental Products Inc.
- EUDAMED SRN
- US-MF-000021065
- Authorised Representative
- Medicom GmbH DE-AR-000005612
Sources (3)
- EUDAMED 20e2a563-0f3e-49b1-9e00-e5c74b2fac70 61 fields · synced Jul 27, 2026
- EUDAMED df0a4b2c-741f-46df-93c4-191ce421e798 61 fields · synced May 18, 2026
- FDA UDI f4f00efb-0fdd-437c-ba61-4a2802a34ade 34 fields · synced May 30, 2026