Identity
- Trade Name
- Parkell® EUDAMEDPain-Free™ FDA UDI
- Generic Name
- Dental material injection cannula, single-use FDA UDI
- Device Name
- Application Tips EUDAMEDGel Application Tips (Pain-Free™ Gel, Etching Gel) FDA UDI
- Model / Reference
- S383 EUDAMEDFDA UDI
- Description
- Gel Application Tips (Pain-Free™ Gel, Etching Gel) FDA UDI
Identifiers
- Catalog Number
- S383 FDA UDI
- Primary DI / UDI-DI
- 10810000526960 EUDAMEDFDA UDI
- Basic UDI-DI
- 081000052NEEDLETIP4ZK EUDAMED
- Unit of Use DI
- 00810000526963 EUDAMED
- FDA Product Code
- KLE FDA UDI
- EMDN Code
- Q019006 DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE EUDAMED
- GMDN Term
- Dental material injection cannula, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3200 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
No
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
Parkell® by Parkell, 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 | 081000052NEEDLETIP4ZK | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Parkell Inc.
- EUDAMED SRN
- US-MF-000003761
- Authorised Representative
- Directa AB SE-AR-000002492
Sources (2)
- EUDAMED e1ccb829-7a6a-4ad3-b29e-770ed7305de8 61 fields · synced Jun 8, 2026
- FDA UDI 7d191f4a-f899-4ab8-b56a-018977256971 35 fields · synced May 30, 2026