Identity
- Trade Name
- Monoject FDA UDI
- Generic Name
- Needle guard FDA UDI
- Device Name
- Safety Needle Holder FDA UDI
- Model / Reference
- 8881225115 FDA UDI
- Description
- Safety Needle Holder FDA UDI
Identifiers
- Catalog Number
- 8881225115 FDA UDI
- Primary DI / UDI-DI
- 20192253051664 FDA UDI
- FDA Product Code
- FMI FDA UDI
- GMDN Term
- Needle guard FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5570 FDA UDI
- 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
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
Category: Needle guard
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 108e8f6b-221d-402f-a3af-ecd61a1a76d4 34 fields · synced Jun 8, 2026