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Sopira Citoject Plastic Sleeve 1.8ml 1pc
FDA UDIClass II (US FDA UDI)
by Kulzer, Inc.
Identity
- Trade Name
- SOPIRA CITOJECT PLASTIC SLEEVE 1.8ML 1PC FDA UDI
- Generic Name
- Dental anaesthesia syringe, reusable FDA UDI
- Device Name
- Syringe,cartridge FDA UDI
- Model / Reference
- 66005419 FDA UDI
- Description
- Syringe,cartridge FDA UDI
Identifiers
- Catalog Number
- 66005419 FDA UDI
- Primary DI / UDI-DI
- J014660054190 FDA UDI
- FDA Product Code
- EJI FDA UDI
- GMDN Term
- Dental anaesthesia syringe, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.6770 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
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 anaesthesia syringe, reusable
Sopira Citoject Plastic Sleeve 1.8ml 1pc by Kulzer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental anaesthesia syringe, reusable.
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- BENCO — BENCO DENTAL SUPPLY CO. · Class II
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class II
- A. Titan Instruments — A.Titan Instruments · Class II
- Dentapen Protective Sleeve — JUVAPLUS SA · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class II
- Dentapen Injector — JUVAPLUS SA · Class II
- Integra® Jarit® — Integra LifeSciences Production Corporation · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Kulzer, Inc.
Sources (1)
- FDA UDI 3bc0ce30-2c47-4a17-aa3c-f785aea62716 35 fields · synced Jun 8, 2026