Identity
- Trade Name
- Insti-Dam® Dispenser White EUDAMEDInsti-Dam Dispenser FDA UDI
- Generic Name
- Surgical instrument guard, reusable FDA UDI
- Device Name
- Non-Sterile Instrument Holders and Organizers Products EUDAMEDDeclassified as non-medical device. Insti-Dam Original Dispenser White FDA UDI
- Model / Reference
- 50Z471A EUDAMEDFDA UDI
- Description
- Declassified as non-medical device. Insti-Dam Original Dispenser White FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840161304049 EUDAMEDFDA UDI
- Basic UDI-DI
- 08401613000233 EUDAMED
- FDA Product Code
- FSM FDA UDI
- EMDN Code
- V0499 CLINICAL USE CONTAINERS (NON-IVD) - OTHER EUDAMED
- GMDN Term
- Surgical instrument guard, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- Not 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 — 124 Millimeter FDA UDIWidth — 124 Millimeter FDA UDIHeight — 156 Millimeter FDA UDI
Category: Instrument transport trolley system
Insti-Dam® Dispenser White by Zirc Dental Products, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Instrument transport trolley system.
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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 | 08401613000233 | 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 (2)
- EUDAMED b1b2b6e0-b517-42d6-bd0a-06a4ed8bf7f2 61 fields · synced Jun 18, 2026
- FDA UDI 9a5b9e84-23aa-426e-a1fa-532cb393577b 35 fields · synced May 25, 2026