Identity
- Trade Name
- Monoject FDA UDI
- Generic Name
- Needle guard FDA UDI
- Device Name
- Safety Needle Holder,Slide Lock, Blue FDA UDI
- Model / Reference
- 8881225110 FDA UDI
- Description
- Safety Needle Holder,Slide Lock, Blue FDA UDI
Identifiers
- Catalog Number
- 8881225110 FDA UDI
- Primary DI / UDI-DI
- 20884521013695 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
Dimensions & Sizes
- Size
- Length — 1 Inch FDA UDI
Category: Needle guard
Monoject by Cardinalhealth — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Needle guard.
- SOL-CARE™ Safety Blood Collection Needle — Sol-Millennium Medical, Inc. · Class II
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- EasyPoint® — Retractable Technologies, Inc. · Class II
- Portex — ICU MEDICAL, INC. · Class II
- Jelco — ICU MEDICAL, INC. · Class II
- SOL-CARE™ Luer Lock Syringe with Safety Needle — Sol-Millennium Medical, Inc. · Class II
- SOL-CARE™ Luer Lock Syringe with Safety Needle — Sol-Millennium Medical, 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 | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cardinalhealth
Sources (1)
- FDA UDI 52bd367c-e304-4801-a90a-e19043fcf10e 37 fields · synced Jun 1, 2026