Identity
- Trade Name
- Compact Steri-Container Plum EUDAMEDFDA UDICompact Steri-Container - Instrument Container - Plum - 1 Count EUDAMED
- Generic Name
- General-purpose bowl, reusable FDA UDI
- Device Name
- Compact Steri-Container Plum EUDAMEDDental Cleaning, Sterilization, Disinfection Accessories EUDAMED"Used to contain instruments during ultrasonic and sterilization procedures Durable, self-lubricating plastic with a securely snapping lid Dimensions: 7-1/8"" x 1-1/2"" x 1-1/2"" Contains Antimicrobial Protection Autoclavable up to 136°C/275F° Washer-disinfect" FDA UDI
- Model / Reference
- 50Z905E EUDAMEDFDA UDI
- Description
- "Used to contain instruments during ultrasonic and sterilization procedures Durable, self-lubricating plastic with a securely snapping lid Dimensions: 7-1/8"" x 1-1/2"" x 1-1/2"" Contains Antimicrobial Protection Autoclavable up to 136°C/275F° Washer-disinfect" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840161300850 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840161300850 EUDAMED0840161300083F EUDAMED
- FDA Product Code
- FSM FDA UDI
- EMDN Code
- S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
- GMDN Term
- General-purpose bowl, reusable 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 — 181 Millimeter FDA UDIWidth — 38 Millimeter FDA UDIHeight — 38 Millimeter FDA UDI
Category: Instrument tray, reusable
Compact Steri-Container Plum 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.
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- Instrument Case — Katena Products, Inc. · Class I
- Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
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- 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-00840161300850 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-00840161300850 | 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 acf9fa0d-0d09-4bc3-8a58-b450ea7b9a11 61 fields · synced Jun 20, 2026
- EUDAMED ff4e2241-894e-4efa-88c0-aca3fbea4d26 61 fields · synced May 17, 2026
- FDA UDI 5e1ec925-848c-48c1-9666-45d9f4f98b72 34 fields · synced May 30, 2026