Identity
- Trade Name
- Monoject FDA UDI
- Generic Name
- Metered-delivery hypodermic syringe FDA UDI
- Device Name
- Control Syringe Luer-Lock Tip FDA UDI
- Model / Reference
- 8881512977 FDA UDI
- Description
- Control Syringe Luer-Lock Tip FDA UDI
Identifiers
- Catalog Number
- 8881512977 FDA UDI
- Primary DI / UDI-DI
- 10192253030686 FDA UDI
- FDA Product Code
- FMF FDA UDI
- GMDN Term
- Metered-delivery hypodermic syringe FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5860 FDA UDI
- Commercial Distribution
- 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
No
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 — 12 Milliliter FDA UDI
Category: Metered-delivery hypodermic syringe
Monoject by Cardinal Health 200, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Cardinal Health 200, LLC
Sources (1)
- FDA UDI f185dd52-3238-4cde-bea1-fc5e4398076c 35 fields · synced Jun 8, 2026