Identity
- Trade Name
- LEADER FDA UDI
- Generic Name
- Autoinjector needle FDA UDI
- Device Name
- LDR Unifine Pentips Plus 33G x 4mm Ultra Micro 100 count FDA UDI
- Model / Reference
- 5075122 FDA UDI
- Description
- LDR Unifine Pentips Plus 33G x 4mm Ultra Micro 100 count FDA UDI
Identifiers
- Catalog Number
- 5075122 FDA UDI
- Primary DI / UDI-DI
- 00096295126914 FDA UDI
- 510(k) Number
- K152339 FDA UDI
- FDA Product Code
- FMI FDA UDI
- GMDN Term
- Autoinjector needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5570 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
No
FDA UDI
Over-the-Counter
Yes
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
- Needle Gauge — 33 Gauge FDA UDILength — 4 Millimeter FDA UDI
Leader by Cardinal Health 110, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K152339 also covers:
- CDMA Quality Choice - Mini Pen Needles — CHAIN DRUG MARKETING ASSOCIATION, INC.
- H.E.B. Unifine Pentips — H. E. BUTT GROCERY COMPANY
- H.E.B. Unifine Pentips Plus — H. E. BUTT GROCERY COMPANY
- H.E.B. Unifine Pentips Plus — H. E. BUTT GROCERY COMPANY
- HEB In-Control Unifine Pentips Plus 4mmx32G — H. E. BUTT GROCERY COMPANY
- 1st Tier Unifine Pentips Mini — OWEN MUMFORD USA INCORPORATED
- Diabetic Outlet - Pentips — OWEN MUMFORD USA INCORPORATED
- Kinray 1st Tier Unifine Pentips Plus — OWEN MUMFORD USA INCORPORATED
- Pentips — OWEN MUMFORD USA INCORPORATED
- Pentips 1st Tier — OWEN MUMFORD USA INCORPORATED
- Pentips 1st Tier — OWEN MUMFORD USA INCORPORATED
- Spartan Nash 1st Tier Unifine Pentips Plus — OWEN MUMFORD USA INCORPORATED
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 110, Inc.
Sources (1)
- FDA UDI e78c7ca5-b2bf-462f-b3d3-8421e35c9366 38 fields · synced Jun 8, 2026