Identity
- Trade Name
- Acuflow FDA UDI
- Generic Name
- Dental anaesthesia syringe cartridge FDA UDI
- Device Name
- The Acuflow Anesthetic Delivery System is a device used for injection of local anesthetics for anesthesia administered prior to, or in conjunction with, dental procedure. FDA UDI
- Model / Reference
- Acuflow FDA UDI
- Description
- The Acuflow Anesthetic Delivery System is a device used for injection of local anesthetics for anesthesia administered prior to, or in conjunction with, dental procedure. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858475006146 FDA UDI
- GMDN Term
- Dental anaesthesia syringe cartridge FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental anaesthesia syringe cartridge
Acuflow by Denterprise International, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental anaesthesia syringe cartridge.
- STRADIS HEALTHCARE — STRADIS MEDICAL, LLC · Class II
- EZ-Flow — Denterprise International, Inc. · 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Denterprise International, Inc.
Sources (1)
- FDA UDI 17ce7de2-849b-4569-8abc-d69204d7cb15 35 fields · synced May 30, 2026