Identity
- Trade Name
- Black Mini Tips EUDAMEDBlack Mini Tip FDA UDI
- Generic Name
- Surgical/emergency suction cannula, non-illuminating, single-use FDA UDI
- Device Name
- Tips EUDAMEDBlack Mini Tips 20pk FDA UDIBlack Mini Tips 100pk FDA UDI
- Model / Reference
- 196 EUDAMEDFDA UDI514 EUDAMEDFDA UDI
- Description
- Black Mini Tips 20pk FDA UDIBlack Mini Tips 100pk FDA UDI
Identifiers
- Catalog Number
- 196 FDA UDI514 FDA UDI
- Primary DI / UDI-DI
- 00883205021663 EUDAMEDFDA UDI00883205021786 EUDAMEDFDA UDI
- Basic UDI-DI
- 0883205-TF032AQ EUDAMED
- FDA Product Code
- EID 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 Mini Tips 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 (6)
- EUDAMED 17de553e-99be-48f8-b149-30aab565b3c5 61 fields · synced Jul 25, 2026
- EUDAMED 27339e45-b940-48e0-bd7c-8e2f0048a081 61 fields · synced May 18, 2026
- FDA UDI 2b6448a5-54cd-4ffb-827e-d22e8c49dc00 35 fields · synced May 29, 2026
- FDA UDI 707e8438-ef1b-4159-90a2-e84119d04223 35 fields · synced May 30, 2026
- EUDAMED fd7c77c0-72b8-4e98-ab0c-15f467047c7b 61 fields · synced Jul 22, 2026
- EUDAMED c0bc3867-6dcb-42b0-93a6-278e79b3bae2 61 fields · synced Jul 25, 2026