Identity
- Trade Name
- Micro 20 ga Tips EUDAMEDMicro 20 Gauge Tip FDA UDI
- Generic Name
- Syringe tip cap FDA UDIDental suction system cannula, single-use FDA UDI
- Device Name
- Tips EUDAMEDMicro 20 Gauge Tips 100pk FDA UDIMicro 20 Gauge Tips 20pk FDA UDI
- Model / Reference
- 1168 EUDAMEDFDA UDI1252 EUDAMEDFDA UDI
- Description
- Micro 20 Gauge Tips 100pk FDA UDIMicro 20 Gauge Tips 20pk FDA UDI
Identifiers
- Catalog Number
- 1252 FDA UDI1168 FDA UDI
- Primary DI / UDI-DI
- 00883205022028 EUDAMEDFDA UDI00883205022080 EUDAMEDFDA UDI
- Basic UDI-DI
- 0883205-TF032AQ EUDAMED
- FDA Product Code
- EIC FDA UDI
- EMDN Code
- Q019006 DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE EUDAMED
- GMDN Term
- Syringe tip cap FDA UDIDental suction system cannula, 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
Micro 20 ga 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 b62800db-c1ef-482c-8831-7a625b3dd1c8 61 fields · synced Jul 12, 2026
- EUDAMED 554e7132-bd6d-4cd9-8658-2fcdbe828c7c 61 fields · synced May 16, 2026
- FDA UDI c60c912e-0d58-413e-b740-a0e11e699c9d 35 fields · synced May 29, 2026
- FDA UDI c75043b9-b425-400d-adca-2a8e0cb50c7c 35 fields · synced May 30, 2026
- EUDAMED d9eedeb0-2b64-4060-8074-d6b08f8b0555 61 fields · synced Jun 19, 2026
- EUDAMED eaed8dca-b094-46b2-b2f7-a34ec1daf1e3 61 fields · synced Jul 12, 2026