Identity
- Trade Name
- Hemostatic Delivery Syringe 20pk 1.2ml EUDAMED1.2ml Plastic Syringe FDA UDI
- Generic Name
- Dental etching solution syringe FDA UDI
- Device Name
- Syringes EUDAMEDHemostatic Delivery Syringe 20pk 1.2ml FDA UDI
- Model / Reference
- 1278 EUDAMEDFDA UDI
- Description
- Hemostatic Delivery Syringe 20pk 1.2ml FDA UDI
Identifiers
- Catalog Number
- 1278 FDA UDI
- Primary DI / UDI-DI
- 00883205033277 EUDAMEDFDA UDI
- Basic UDI-DI
- 0883205-TF044AX EUDAMED
- FDA Product Code
- EIC FDA UDI
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Dental etching solution syringe 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
Yes
FDA UDI
Category: Dental etching solution syringe
1.2ml Plastic Syringe by Ultradent Products, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ultradent Products, Inc.
Sources (2)
- FDA UDI 9eb32c99-a077-476a-905a-7a0ed799e63c 35 fields · synced Jul 19, 2026
- EUDAMED 0d866e2e-1c4d-4a0b-b0c5-21b59df8419f 61 fields · synced Jul 19, 2026