Identity
- Trade Name
- Monoject FDA UDI
- Generic Name
- Tuberculin/allergy syringe/needle, safety FDA UDI
- Device Name
- 1 mL Tuberculin Syringe Permanent Needle FDA UDI
- Model / Reference
- 1180128012 FDA UDI
- Description
- 1 mL Tuberculin Syringe Permanent Needle FDA UDI
Identifiers
- Catalog Number
- 1180128012 FDA UDI
- Primary DI / UDI-DI
- 10884521013544 FDA UDI
- FDA Product Code
- FMF FDA UDI
- GMDN Term
- Tuberculin/allergy syringe/needle, safety 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
Category: Tuberculin/allergy syringe/needle, safety
Monoject by Cardinalhealth — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tuberculin/allergy syringe/needle, safety.
- HEPRO.US - Tuberculin Syringe attached needle, 1ml/cc 25G x 5/8" — HEPRO.US INC. · Class II
- Magellan — Cardinal Health 200, LLC · Class II
- Monoject — Cardinal Health 200, LLC · Class II
- Monoject — Cardinal Health 200, LLC · Class II
- Monoject — Cardinal Health 200, LLC · Class II
- Magellan — Cardinal Health 200, LLC · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- Monoject — Cardinal Health 200, LLC · 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 |
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Manufacturer
- Manufacturer
- Cardinalhealth
Sources (1)
- FDA UDI 06eae493-7287-4b42-8ef2-7d214ce091dc 34 fields · synced Jun 1, 2026