Identity
- Trade Name
- Black Micro FX Tip EUDAMEDFDA UDI
- Generic Name
- Surgical/emergency suction cannula, non-illuminating, single-use FDA UDI
- Device Name
- Tips EUDAMEDBlack Micro FX Tips 100pk FDA UDI
- Model / Reference
- 1357 EUDAMEDFDA UDI
- Description
- Black Micro FX Tips 100pk FDA UDI
Identifiers
- Catalog Number
- 1357 FDA UDI
- Primary DI / UDI-DI
- 00883205022141 EUDAMEDFDA UDI
- Basic UDI-DI
- 0883205-TF032AQ EUDAMED
- FDA Product Code
- EIY FDA UDI
- EMDN Code
- Q019006 DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE EUDAMED
- GMDN Term
- Surgical/emergency suction cannula, non-illuminating, single-use 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
Yes
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
No
FDA UDI
Category: Dental material injection cannula, single-use
Black Micro FX Tip by Ultradent Products, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 0883205-TF032AQ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ultradent Products, Inc.
- EUDAMED SRN
- US-MF-000013697
- Authorised Representative
- Ultradent Products GmbH DE-AR-000006666
Sources (3)
- EUDAMED 72280abd-014f-45ab-a0fd-829dd61e250e 61 fields · synced Jun 18, 2026
- FDA UDI a7c18823-2988-4c9a-a6fa-3944df91693e 35 fields · synced May 30, 2026
- EUDAMED 7334b7af-0ce2-4ea7-8c01-36c97953c539 61 fields · synced Jun 18, 2026