Identity
- Trade Name
- MONOVAC FDA UDI
- Generic Name
- Irrigation syringe FDA UDI
- Device Name
- Pre-Tipped Irrigator Syringe, 3cc, 27ga, Side Vented, Monoject Style FDA UDI
- Model / Reference
- INT-MPT0327 FDA UDI
- Description
- Pre-Tipped Irrigator Syringe, 3cc, 27ga, Side Vented, Monoject Style FDA UDI
Identifiers
- Catalog Number
- INT-MPT0327 FDA UDI
- Primary DI / UDI-DI
- D832INTMPT03271 FDA UDI
- FDA Product Code
- EIC FDA UDI
- GMDN Term
- Irrigation syringe 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
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Irrigation syringe
Monovac by Plasdent Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Irrigation syringe.
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- IRRIJET® Single-Use — CooperSurgical, Inc. · Class I
- Dover — Cardinal Health 200, LLC · Class I
- Medline — MEDLINE INDUSTRIES, INC. · Class I
- HSW HENKE-JECT® — Henke-Sass, Wolf GmbH · Class II
- Monoject — Cardinalhealth · Class I
- Olympus — Olympus Winter & Ibe GmbH · 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 I | Pending data |
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Manufacturer
- Manufacturer
- Plasdent Corp.
Sources (1)
- FDA UDI 02f69a8b-eedd-433a-9f93-71168d52bed5 34 fields · synced May 31, 2026