Identity
- Trade Name
- TopRx 1st Tier Pentips FDA UDI
- Generic Name
- Autoinjector needle FDA UDI
- Device Name
- TopRx 1st Tier Pentips pen needles - 4mm x 32G FDA UDI
- Model / Reference
- AN 3440TRX FDA UDI
- Description
- TopRx 1st Tier Pentips pen needles - 4mm x 32G FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00761059440871 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
- 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
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
- Length — 4 Millimeter FDA UDINeedle Gauge — 32 Gauge FDA UDI
Category: Autoinjector needle
TopRx 1st Tier Pentips by Owen Mumford Usa Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Autoinjector needle.
- MICRON, droplet pen needle — HTL STREFA S A · Class II
- SureFine Pen Needle 31Gx8mm — SHINA MED CORPORATION · Class II
- EasyDrip Pen Needles 30G 8mm — Sandstone Medical (Suzhou) Inc. · Class II
- droplet®, pen needles — HTL STREFA S A · Class II
- Nano 2nd Gen — embecta Medical II LLC · Class II
- BD Ultra-Fine — BECTON DICKINSON PEN LIMITED · Class II
- Insulin Pen Needle — Berpu Medical Technology Co., Ltd · Class II
- ONE-CARE Pen Needles — MediVena, LLC · Class II
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
- Owen Mumford Usa Incorporated
Sources (1)
- FDA UDI 5a35c192-5741-4e92-b8cc-a054e8e3692c 36 fields · synced May 30, 2026