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Insti-Dam® - Insti-Dam® Dispenser - White - 1 Count
EUDAMEDFDA UDIClass I (EU MDR)
Ref 50Z471
Identity
- Trade Name
- Insti-Dam® - Insti-Dam® Dispenser - White - 1 Count EUDAMEDInsti-Dam Dispenser FDA UDI
- Generic Name
- Surgical instrument guard, reusable FDA UDI
- Device Name
- Non-Sterile Dental Isolation and Barrier Devices – Single Use EUDAMEDInsti-Dam Original Dispenser Neon Blue FDA UDI
- Model / Reference
- 50Z471 EUDAMED50Z471N FDA UDI
- Description
- Insti-Dam Original Dispenser Neon Blue FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840161304056 EUDAMEDFDA UDI
- Basic UDI-DI
- 08401613000335 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
- 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® - Insti-Dam® Dispenser - White - 1 Count by Zirc Dental Products, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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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 | 08401613000335 | 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 2c774a0b-3d62-43b2-985b-a210dd73fd01 61 fields · synced Jul 24, 2026
- FDA UDI 978e27f7-7d26-4a0e-b525-219e0cb44835 34 fields · synced May 29, 2026