Identity
- Trade Name
- EZ-ID Tape System Jewel EUDAMEDE-Z ID Tape FDA UDI
- Generic Name
- Surgical instrument track identification tape FDA UDI
- Device Name
- Identification Accessories for Dental Instruments EUDAMEDDeclassified as non-medical device. "EZ-ID Tape System Jewel, System comes with eight 3 ft. rolls of tape and a rack that holds them organized and accessible for use 2x3ft rolls of Plum 2x3ft rolls of Midnight Blue 1x3ft roll of Gray 1x3ft roll of Teal 1x3ft roll of Red 1x3ft roll of Copper" FDA UDI
- Model / Reference
- 70Z315 EUDAMEDFDA UDI
- Description
- Declassified as non-medical device. "EZ-ID Tape System Jewel, System comes with eight 3 ft. rolls of tape and a rack that holds them organized and accessible for use 2x3ft rolls of Plum 2x3ft rolls of Midnight Blue 1x3ft roll of Gray 1x3ft roll of Teal 1x3ft roll of Red 1x3ft roll of Copper" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840161305664 EUDAMEDFDA UDI
- Basic UDI-DI
- 08401613000437 EUDAMED
- FDA Product Code
- LYV FDA UDI
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Surgical instrument track identification tape 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 — 91.4 Centimeter FDA UDI
EZ-ID Tape System Jewel by Zirc Dental Products, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 08401613000437 | 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 cc69137d-81e4-4589-b1d1-e00688265870 61 fields · synced Jul 27, 2026
- FDA UDI a9f62e0d-1be4-4951-bea0-12ca0715df70 35 fields · synced May 30, 2026