Identity
- Trade Name
- 1.2ml Plastic Syringe FDA UDI
- Generic Name
- General-purpose syringe, single-use FDA UDI
- Device Name
- 1.2ml Plastic Syringe 20pk FDA UDI
- Model / Reference
- 124 FDA UDI
- Description
- 1.2ml Plastic Syringe 20pk FDA UDI
Identifiers
- Catalog Number
- 124 FDA UDI
- Primary DI / UDI-DI
- 00883205019394 FDA UDI
- FDA Product Code
- EIC FDA UDI
- GMDN Term
- General-purpose syringe, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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: General-purpose syringe, single-use
1.2ml Plastic Syringe by Ultradent Products, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose syringe, single-use.
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- SURGYCO — Surgyco LLC · Class I
- NAMIC — MEDLINE INDUSTRIES, INC. · Class II
- HSW HENKE-JECT® — Henke-Sass, Wolf GmbH · Class II
- BD Safety-Lok — BECTON DICKINSON AND COMPANY · Class II
- SURGYCO — Surgyco LLC · Class I
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 00104d41-34e3-4c83-aed4-21691c461e79 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 18, 2026