← Back to catalogue
Ergo Grip - Mirror Handle - Simple Stem - Teal - 1 Count
EUDAMEDFDA UDIClass I (EU MDR)
Ref 50Z347J
Identity
- Trade Name
- Ergo Grip - Mirror Handle - Simple Stem - Teal - 1 Count EUDAMEDMouth Mirror Handle (Simple Stem) FDA UDI
- Generic Name
- Dental mirror, reusable FDA UDI
- Device Name
- Crystal HD Mouth Mirrors EUDAMEDErgo Grip Handle Simple Stem Teal FDA UDI
- Model / Reference
- 50Z347J EUDAMEDFDA UDI
- Description
- Ergo Grip Handle Simple Stem Teal FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840161307989 EUDAMEDFDA UDI
- Basic UDI-DI
- 0840161300012Z EUDAMED
- FDA Product Code
- EAX FDA UDI
- EMDN Code
- L160201 DENTAL MIRRORS AND HANDLES, REUSABLE EUDAMED
- GMDN Term
- Dental mirror, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 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 — 13.3 Centimeter FDA UDI
Ergo Grip - Mirror Handle - Simple Stem - Teal - 1 Count by Zirc Dental Products, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 0840161300012Z | 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 (2)
- EUDAMED db8a56ef-906f-4be3-8b22-631edb138888 61 fields · synced Jun 19, 2026
- FDA UDI 01033535-fadd-42bf-a846-250fca7dce16 34 fields · synced May 30, 2026