Identity
- Trade Name
- Monoject FDA UDI
- Generic Name
- Irrigation syringe FDA UDI
- Device Name
- 140 mL Piston Syringe,Luer-Lock Tip FDA UDI
- Model / Reference
- 8881114063 FDA UDI
- Description
- 140 mL Piston Syringe,Luer-Lock Tip FDA UDI
Identifiers
- Catalog Number
- 8881114063 FDA UDI
- Primary DI / UDI-DI
- 20884521128917 FDA UDI
- FDA Product Code
- FMF FDA UDI
- GMDN Term
- Irrigation syringe FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5860 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 140 Milliliter FDA UDITotal Volume — 12 Milliliter FDA UDITotal Volume — 20 Milliliter FDA UDITotal Volume — 60 Milliliter FDA UDITotal Volume — 6 Milliliter FDA UDITotal Volume — 35 Milliliter FDA UDITotal Volume — 3 Milliliter FDA UDITotal Volume — 18 Gallon FDA UDI
Monoject by Cardinalhealth — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Cardinalhealth
Sources (1)
- FDA UDI 27ab097f-a9c0-4d8f-99dc-78a3d8f33dce 38 fields · synced Jun 6, 2026